target
sequence
pubmed_id
int64
1.28M
26.5M
text_combined
stringlengths
279
8.41k
text
sequence
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "BACKGROUND" ]
24,491,034
the emergence of hiv as a chronic condition means that people living with hiv are required to take more responsibility for the self-management of their condition , including making physical , emotional and social adjustments . this paper describes the design and evaluation of positive outlook , an online program aiming to enhance the self-management skills of gay men living with hiv . this study is designed as a randomised controlled trial in which men living with hiv in australia will be assigned to either an intervention group or usual care control group . the intervention group will participate in the online group program ` positive outlook ' . the program is based on self-efficacy theory and uses a self-management approach to enhance skills , confidence and abilities to manage the psychosocial issues associated with hiv in daily life . participants will access the program for a minimum of @ minutes per week over seven weeks . primary outcomes are domain specific self-efficacy , hiv related quality of life , and outcomes of health education . secondary outcomes include : depression , anxiety and stress ; general health and quality of life ; adjustment to hiv ; and social support . data collection will take place at baseline , completion of the intervention ( or eight weeks post randomisation ) and at @ week follow-up . results of the positive outlook study will provide information regarding the effectiveness of online group programs improving health related outcomes for men living with hiv . actrn@ .
[ "the emergence of hiv as a chronic condition means that people living with hiv are required to take more responsibility for the self-management of their condition , including making physical , emotional and social adjustments .", "this paper describes the design and evaluation of positive outlook , an online program aiming to enhance the self-management skills of gay men living with hiv .", "this study is designed as a randomised controlled trial in which men living with hiv in australia will be assigned to either an intervention group or usual care control group .", "the intervention group will participate in the online group program ` positive outlook ' .", "the program is based on self-efficacy theory and uses a self-management approach to enhance skills , confidence and abilities to manage the psychosocial issues associated with hiv in daily life .", "participants will access the program for a minimum of @ minutes per week over seven weeks .", "primary outcomes are domain specific self-efficacy , hiv related quality of life , and outcomes of health education .", "secondary outcomes include : depression , anxiety and stress ; general health and quality of life ; adjustment to hiv ; and social support .", "data collection will take place at baseline , completion of the intervention ( or eight weeks post randomisation ) and at @ week follow-up .", "results of the positive outlook study will provide information regarding the effectiveness of online group programs improving health related outcomes for men living with hiv .", "actrn@ ." ]
[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
20,497,432
the aim of this study was to evaluate the efficacy , safety and complications of orbital steroid injection versus oral steroid therapy in the management of thyroid-related ophthalmopathy . a total of @ patients suffering from thyroid ophthalmopathy were included in this study . patients were randomized into two groups : group i included @ patients treated with oral prednisolone and group ii included @ patients treated with peribulbar triamcinolone orbital injection . only @ patients in both groups ( @ female and @ male ) completed the study . both groups showed improvement in symptoms and in clinical evidence of inflammation with improvement of eye movement and proptosis in most cases . mean exophthalmometry value before treatment was @ @ mm that decreased to @ @ mm in group i , compared with @ @ mm that decreased to @ @ mm in group ii . mean initial clinical activity score was @ @ and @ @ for group i and group ii before treatment , respectively , which dropped to @ @ and @ @ , @ months after treatment , respectively . there was no change in the best-corrected visual acuity in both groups . there was an increase in body weight , blood sugar , blood pressure and gastritis in group i in @ % , @ % , @ % and @ % , respectively , compared with @ % , @ % , @ % and @ % in group ii . no adverse local side effects were observed in group ii . orbital steroid injection for thyroid-related ophthalmopathy is effective and safe . it eliminates the adverse reactions associated with oral corticosteroid use .
[ "the aim of this study was to evaluate the efficacy , safety and complications of orbital steroid injection versus oral steroid therapy in the management of thyroid-related ophthalmopathy .", "a total of @ patients suffering from thyroid ophthalmopathy were included in this study .", "patients were randomized into two groups : group i included @ patients treated with oral prednisolone and group ii included @ patients treated with peribulbar triamcinolone orbital injection .", "only @ patients in both groups ( @ female and @ male ) completed the study .", "both groups showed improvement in symptoms and in clinical evidence of inflammation with improvement of eye movement and proptosis in most cases .", "mean exophthalmometry value before treatment was @ @ mm that decreased to @ @ mm in group i , compared with @ @ mm that decreased to @ @ mm in group ii .", "mean initial clinical activity score was @ @ and @ @ for group i and group ii before treatment , respectively , which dropped to @ @ and @ @ , @ months after treatment , respectively .", "there was no change in the best-corrected visual acuity in both groups .", "there was an increase in body weight , blood sugar , blood pressure and gastritis in group i in @ % , @ % , @ % and @ % , respectively , compared with @ % , @ % , @ % and @ % in group ii .", "no adverse local side effects were observed in group ii .", "orbital steroid injection for thyroid-related ophthalmopathy is effective and safe .", "it eliminates the adverse reactions associated with oral corticosteroid use ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
19,062,107
the aim of this prospective randomized study was to examine whether active counseling and more liberal oral fluid intake decrease postoperative pain , nausea and vomiting in pediatric ambulatory tonsillectomy . families , whose child was admitted for ambulatory tonsillectomy or adenotonsillectomy , were randomly assigned to the study groups ( n = @ ; @ families in each group ) . the intervention group received the fasting instructions with face-to-face counseling for the child 's active preoperative nutrition , and the control group the fasting instructions according to the hospital 's standard procedure . the level of postoperative pain and nausea was scored in the postanesthesia care unit ( pacu ) during the first postoperative hour , as well as at @ , @ , @ and @h postoperatively . the first scoring in pacu was performed by the attending nurse with a @-@ scale . the rest of the estimations were made independently and simultaneously by the children using a vas scale , and by the parents using a @-@ scale . the children in the control group were in more pain in the pacu than the children in the intervention group , and the difference between the groups was statistically significant ( p = @ ) . all pain scores , according to the children and the parents , increased after the surgery . in both groups the highest score values were found at home @h after surgery , and no significant difference was found between the study groups . on the first postoperative morning , the children in the control group were in pain ( p = @ ) . the children did not have significant nausea in the pacu , but the nausea increased postoperatively . four hours after surgery the children were most nauseous according to all estimations ( @ % , n = @ ) . more than half of the children vomited and most vomited clotted blood . nausea and vomiting decreased during the evening of the surgery , but six children vomited the next morning , four of them vomited blood . the incidence and intensity of postoperative nausea and vomiting between the intervention and control groups were not statistically significant . however , preoperative nutritional counseling and more liberal per oral fluid intake appeared to have a positive effect on the children 's well-being and helped them to better tolerate postoperative nausea and vomiting . the preoperative counseling about active preoperative nutrition significantly reduces the child 's pain during the first posttonsillectomy hours and might prepare the child to better tolerate the stress of potential postoperative nausea and vomiting .
[ "the aim of this prospective randomized study was to examine whether active counseling and more liberal oral fluid intake decrease postoperative pain , nausea and vomiting in pediatric ambulatory tonsillectomy .", "families , whose child was admitted for ambulatory tonsillectomy or adenotonsillectomy , were randomly assigned to the study groups ( n = @ ; @ families in each group ) .", "the intervention group received the fasting instructions with face-to-face counseling for the child 's active preoperative nutrition , and the control group the fasting instructions according to the hospital 's standard procedure .", "the level of postoperative pain and nausea was scored in the postanesthesia care unit ( pacu ) during the first postoperative hour , as well as at @ , @ , @ and @h postoperatively .", "the first scoring in pacu was performed by the attending nurse with a @-@ scale .", "the rest of the estimations were made independently and simultaneously by the children using a vas scale , and by the parents using a @-@ scale .", "the children in the control group were in more pain in the pacu than the children in the intervention group , and the difference between the groups was statistically significant ( p = @ ) .", "all pain scores , according to the children and the parents , increased after the surgery .", "in both groups the highest score values were found at home @h after surgery , and no significant difference was found between the study groups .", "on the first postoperative morning , the children in the control group were in pain ( p = @ ) .", "the children did not have significant nausea in the pacu , but the nausea increased postoperatively .", "four hours after surgery the children were most nauseous according to all estimations ( @ % , n = @ ) .", "more than half of the children vomited and most vomited clotted blood .", "nausea and vomiting decreased during the evening of the surgery , but six children vomited the next morning , four of them vomited blood .", "the incidence and intensity of postoperative nausea and vomiting between the intervention and control groups were not statistically significant .", "however , preoperative nutritional counseling and more liberal per oral fluid intake appeared to have a positive effect on the children 's well-being and helped them to better tolerate postoperative nausea and vomiting .", "the preoperative counseling about active preoperative nutrition significantly reduces the child 's pain during the first posttonsillectomy hours and might prepare the child to better tolerate the stress of potential postoperative nausea and vomiting ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
19,769,482
to explore the effects of gengnianle ( gnl , also called perimenopausal depression relieving formula ) , a defined formula of chinese medicinal herbs in relieving perimenopausal depression in chinese women . between september @ and april @ , @ chinese women were randomized into a gnl group ( n = @ ) and a control group which received tibolone ( n = @ ) using a randomization chart . depression was rated with the @-item hamilton depression scale ( hamd ) . the serum levels of follicle stimulating hormone ( fsh ) , luteinizing hormone ( lh ) , and estradiol ( e ( @ ) ) were detected before and after the treatment . after @ weeks of treatment , hamd scores in both groups decreased significantly ( p < @ ) with no significant difference between the groups ( p > @ ) . the levels of fsh decreased significantly and the level of e ( @ ) increased significantly in both groups , and they changed more in the control group . no side-effect of treatment was reported in either group during treatment . the chinese medicinal formula gnl showed promise in relieving perimenopausal depression and merits further study .
[ "to explore the effects of gengnianle ( gnl , also called perimenopausal depression relieving formula ) , a defined formula of chinese medicinal herbs in relieving perimenopausal depression in chinese women .", "between september @ and april @ , @ chinese women were randomized into a gnl group ( n = @ ) and a control group which received tibolone ( n = @ ) using a randomization chart .", "depression was rated with the @-item hamilton depression scale ( hamd ) .", "the serum levels of follicle stimulating hormone ( fsh ) , luteinizing hormone ( lh ) , and estradiol ( e ( @ ) ) were detected before and after the treatment .", "after @ weeks of treatment , hamd scores in both groups decreased significantly ( p < @ ) with no significant difference between the groups ( p > @ ) .", "the levels of fsh decreased significantly and the level of e ( @ ) increased significantly in both groups , and they changed more in the control group .", "no side-effect of treatment was reported in either group during treatment .", "the chinese medicinal formula gnl showed promise in relieving perimenopausal depression and merits further study ." ]
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
26,077,436
topical formulations of nonsteroidal anti-inflammatory drugs ( nsaids ) are generally considered to be safer alternatives to oral nsaids due to lower systemic absorption . we conducted randomized , crossover studies that compared the pharmacokinetics ( pk ) , bioequivalence and safety of topical diclofenac sodium @ % twice daily ( bid ) , diclofenac sodium @ % four times daily ( qid ) and oral diclofenac sodium in healthy subjects . the results of three bioequivalence studies are reviewed . healthy adult subjects ( n = @ ) applied topical diclofenac sodium @ % solution ( @ mg/@ ml ) bid ; or @ % solution ( @ mg/@ drops ) qid to each knee for @ consecutive days separated by a washout period . subjects ( n = @ ) in one study also received oral diclofenac sodium @ mg bid for @ days . plasma diclofenac concentrations were determined from serial blood samples collected on days @ and @ ( steady state ) , and diclofenac pk parameters were estimated by noncompartmental methods . the studies demonstrated comparable bioequivalence between the @ % and @ % topical solutions as well as lower systemic exposure compared to oral dosing ( approximately @ % less ) . daily systemic exposure was comparable between the two formulations with only a @ % difference in the aucss ( @-@ ) ( p = @ ) . furthermore , both topical solutions demonstrated delayed elimination with a t ( @/@ ) of @ - to @-fold longer , as compared to oral diclofenac . the @ % solution provided more consistent dosing relative to the @ % solution when comparing aucss ( @-@ ) and cmaxss across studies . mild application site reactions were the most common treatment-emergent adverse event reported with topical diclofenac . the steady-state pk profile of topical diclofenac @ % solution administered bid is similar to that of the @ % solution administered qid . systemic exposure to diclofenac is substantially lower after topical application as compared to oral administration . ( study @ was registered with clinicaltrials.gov ; nct@ ; https://clinicaltrials.gov/ct@/results?term=@&search=search ) .
[ "topical formulations of nonsteroidal anti-inflammatory drugs ( nsaids ) are generally considered to be safer alternatives to oral nsaids due to lower systemic absorption .", "we conducted randomized , crossover studies that compared the pharmacokinetics ( pk ) , bioequivalence and safety of topical diclofenac sodium @ % twice daily ( bid ) , diclofenac sodium @ % four times daily ( qid ) and oral diclofenac sodium in healthy subjects .", "the results of three bioequivalence studies are reviewed .", "healthy adult subjects ( n = @ ) applied topical diclofenac sodium @ % solution ( @ mg/@ ml ) bid ; or @ % solution ( @ mg/@ drops ) qid to each knee for @ consecutive days separated by a washout period .", "subjects ( n = @ ) in one study also received oral diclofenac sodium @ mg bid for @ days .", "plasma diclofenac concentrations were determined from serial blood samples collected on days @ and @ ( steady state ) , and diclofenac pk parameters were estimated by noncompartmental methods .", "the studies demonstrated comparable bioequivalence between the @ % and @ % topical solutions as well as lower systemic exposure compared to oral dosing ( approximately @ % less ) .", "daily systemic exposure was comparable between the two formulations with only a @ % difference in the aucss ( @-@ ) ( p = @ ) .", "furthermore , both topical solutions demonstrated delayed elimination with a t ( @/@ ) of @ - to @-fold longer , as compared to oral diclofenac .", "the @ % solution provided more consistent dosing relative to the @ % solution when comparing aucss ( @-@ ) and cmaxss across studies .", "mild application site reactions were the most common treatment-emergent adverse event reported with topical diclofenac .", "the steady-state pk profile of topical diclofenac @ % solution administered bid is similar to that of the @ % solution administered qid .", "systemic exposure to diclofenac is substantially lower after topical application as compared to oral administration .", "( study @ was registered with clinicaltrials.gov ; nct@ ; https://clinicaltrials.gov/ct@/results?term=@&search=search ) ." ]
[ "BACKGROUND", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
20,656,965
no long-term studies have been reported on the effect of training programs on driving after stroke . the authors ' primary aim was to determine the effect of simulator versus cognitive rehabilitation therapy on fitness-to-drive at @ years poststroke . a second aim was to investigate differences in clinical characteristics between stroke survivors who resumed and stopped driving . in a previously reported randomized controlled trial , @ stroke survivors received @ hours of simulator training ( n = @ ) or cognitive therapy ( n = @ ) . in this @-year follow-up study , @ participants were reassessed . fitness-to-drive decisions were obtained from medical , visual , neuropsychological , and on-road tests ; @ participants ( simulator group , n = @ ; cognitive group , n = @ ) completed all assessments . the primary outcome measures were fitness-to-drive decision and current driving status . the authors found that @ years after stroke , @ of @ participants ( @ % ) in the simulator group were considered fit to drive , compared with @ of @ ( @ % ) in the cognitive group ( p = @ ) ; @ of @ ( @ % ) participants were driving . current drivers were younger ( p = @ ) , had higher barthel scores ( p = @ ) , had less comorbidity ( p = @ ) , and were less severely depressed ( p = @ ) than those who gave up driving . the advantage of simulator-based driving training over cognitive rehabilitation therapy , evident at @ months poststroke , had faded @ years later . poststroke drivers were younger and less severely affected and depressed than nondrivers .
[ "no long-term studies have been reported on the effect of training programs on driving after stroke .", "the authors ' primary aim was to determine the effect of simulator versus cognitive rehabilitation therapy on fitness-to-drive at @ years poststroke .", "a second aim was to investigate differences in clinical characteristics between stroke survivors who resumed and stopped driving .", "in a previously reported randomized controlled trial , @ stroke survivors received @ hours of simulator training ( n = @ ) or cognitive therapy ( n = @ ) .", "in this @-year follow-up study , @ participants were reassessed .", "fitness-to-drive decisions were obtained from medical , visual , neuropsychological , and on-road tests ; @ participants ( simulator group , n = @ ; cognitive group , n = @ ) completed all assessments .", "the primary outcome measures were fitness-to-drive decision and current driving status .", "the authors found that @ years after stroke , @ of @ participants ( @ % ) in the simulator group were considered fit to drive , compared with @ of @ ( @ % ) in the cognitive group ( p = @ ) ; @ of @ ( @ % ) participants were driving .", "current drivers were younger ( p = @ ) , had higher barthel scores ( p = @ ) , had less comorbidity ( p = @ ) , and were less severely depressed ( p = @ ) than those who gave up driving .", "the advantage of simulator-based driving training over cognitive rehabilitation therapy , evident at @ months poststroke , had faded @ years later .", "poststroke drivers were younger and less severely affected and depressed than nondrivers ." ]
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
17,889,242
the potential of insecticide-treated bednets ( itns ) to contribute to child survival has been well documented in randomised controlled trials . itn coverage has increased rapidly in kenya from @ % in @ to @ % in @ . we aimed to assess the extent to which this investment has led to improvements in child survival . a dynamic cohort of about @ children aged @-@ months were enumerated three times at yearly intervals in @ rural clusters located in four districts of kenya . the effect of itn use on mortality was assessed with poisson regression to take account of potential effect-modifying and confounding covariates . @ children died over @ years . overall mortality rates were much the same in the first and second years of the study ( @ per @ person-years in the first year and @ per @ person-years in the second ) . after adjustment for age , time period , and a number of other possible confounding variables , itn use was associated with a @ % reduction in mortality ( mortality rate ratio @ , @ % ci @-@ @ ; p = @ ) . this level of protection corresponds to about seven deaths averted for every @ itns distributed . a combined approach of social marketing followed by mass free distribution of itns translated into child survival effects that are comparable with those seen in previous randomised controlled trials .
[ "the potential of insecticide-treated bednets ( itns ) to contribute to child survival has been well documented in randomised controlled trials .", "itn coverage has increased rapidly in kenya from @ % in @ to @ % in @ .", "we aimed to assess the extent to which this investment has led to improvements in child survival .", "a dynamic cohort of about @ children aged @-@ months were enumerated three times at yearly intervals in @ rural clusters located in four districts of kenya .", "the effect of itn use on mortality was assessed with poisson regression to take account of potential effect-modifying and confounding covariates .", "@ children died over @ years .", "overall mortality rates were much the same in the first and second years of the study ( @ per @ person-years in the first year and @ per @ person-years in the second ) .", "after adjustment for age , time period , and a number of other possible confounding variables , itn use was associated with a @ % reduction in mortality ( mortality rate ratio @ , @ % ci @-@ @ ; p = @ ) .", "this level of protection corresponds to about seven deaths averted for every @ itns distributed .", "a combined approach of social marketing followed by mass free distribution of itns translated into child survival effects that are comparable with those seen in previous randomised controlled trials ." ]
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
23,615,091
cortical stimulation mapping ( csm ) commonly uses visual naming to determine resection margins in the dominant hemisphere of patients with epilepsy . visual naming alone may not identify all language sites in resection-prone areas , prompting additional tasks for comprehensive language mapping . to demonstrate word-finding distinctions between visual , auditory , and reading modalities during csm and the percentage of modality-specific language sites within dominant hemisphere subregions . twenty-eight patients with epilepsy underwent csm by the use of visual , auditory , and sentence-completion tasks . hierarchical logistic regression analyzed errors to identify language sites and provide modality-specific percentages within subregions . the percentage of sites classified as language sites based on auditory naming was twice as high in anterior temporal regions compared with visual naming , marginally higher in posterior temporal areas , and comparable in parietal regions . sentence completion was comparable to visual and auditory naming in parietal regions and lower in most temporal areas . of @ sites tested with both visual and auditory naming , @ sites were distinctly auditory , whereas @ sites were distinctly visual . the remaining sites overlapped . distinct cortical areas were found for distinct input modalities , with language sites in anterior tip regions found most often by using auditory naming . the vulnerability of anterior temporal tip regions to resection in this population and distinct sites for each modality suggest that a multimodality approach may be needed to spare crucial language sites , if sparing those sites can be shown to significantly reduce the rate of postoperative language deficits without sacrificing seizure control .
[ "cortical stimulation mapping ( csm ) commonly uses visual naming to determine resection margins in the dominant hemisphere of patients with epilepsy .", "visual naming alone may not identify all language sites in resection-prone areas , prompting additional tasks for comprehensive language mapping .", "to demonstrate word-finding distinctions between visual , auditory , and reading modalities during csm and the percentage of modality-specific language sites within dominant hemisphere subregions .", "twenty-eight patients with epilepsy underwent csm by the use of visual , auditory , and sentence-completion tasks .", "hierarchical logistic regression analyzed errors to identify language sites and provide modality-specific percentages within subregions .", "the percentage of sites classified as language sites based on auditory naming was twice as high in anterior temporal regions compared with visual naming , marginally higher in posterior temporal areas , and comparable in parietal regions .", "sentence completion was comparable to visual and auditory naming in parietal regions and lower in most temporal areas .", "of @ sites tested with both visual and auditory naming , @ sites were distinctly auditory , whereas @ sites were distinctly visual .", "the remaining sites overlapped .", "distinct cortical areas were found for distinct input modalities , with language sites in anterior tip regions found most often by using auditory naming .", "the vulnerability of anterior temporal tip regions to resection in this population and distinct sites for each modality suggest that a multimodality approach may be needed to spare crucial language sites , if sparing those sites can be shown to significantly reduce the rate of postoperative language deficits without sacrificing seizure control ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
8,532,270
to determine if suppressive acyclovir therapy given to term gravidas experiencing a first episode of genital herpes simplex virus ( hsv ) - infection during pregnancy decreases the need for cesarean delivery for that indication . forty-six pregnant women with first episodes of genital herpes during pregnancy were randomly assigned to receive oral acyclovir @ mg or placebo , three times per day , from @ weeks ' gestation until delivery as part of a prospective , double-blind trial . herpes simplex virus cultures were obtained when patients presented for delivery . vaginal delivery was permitted if no clinical recurrence was present ; otherwise , a cesarean was performed . neonatal hsv cultures were obtained and infants were followed-up clinically . none of the @ patients treated with acyclovir and nine of @ ( @ % ) treated with placebo had clinical evidence of recurrent genital herpes at delivery ( odds ratio [ or ] @ , @ % confidence interval [ ci ] @-@ @ ; p = @ ) . no woman treated with acyclovir had a cesarean for herpes , compared with nine of @ ( @ % ) of those treated with placebo ( or @ , ci @-@ @ ; p = @ ) . no patient in either treatment group experienced asymptomatic genital viral shedding at delivery . no neonate had evidence of herpes infection or adverse effects from acyclovir . suppressive acyclovir therapy reduced the need for cesarean for recurrent herpes in women whose first clinical episode of genital hsv occurred during pregnancy . suppressive acyclovir treatment did not increase asymptomatic viral shedding and was not harmful to the term fetus .
[ "to determine if suppressive acyclovir therapy given to term gravidas experiencing a first episode of genital herpes simplex virus ( hsv ) - infection during pregnancy decreases the need for cesarean delivery for that indication .", "forty-six pregnant women with first episodes of genital herpes during pregnancy were randomly assigned to receive oral acyclovir @ mg or placebo , three times per day , from @ weeks ' gestation until delivery as part of a prospective , double-blind trial .", "herpes simplex virus cultures were obtained when patients presented for delivery .", "vaginal delivery was permitted if no clinical recurrence was present ; otherwise , a cesarean was performed .", "neonatal hsv cultures were obtained and infants were followed-up clinically .", "none of the @ patients treated with acyclovir and nine of @ ( @ % ) treated with placebo had clinical evidence of recurrent genital herpes at delivery ( odds ratio [ or ] @ , @ % confidence interval [ ci ] @-@ @ ; p = @ ) .", "no woman treated with acyclovir had a cesarean for herpes , compared with nine of @ ( @ % ) of those treated with placebo ( or @ , ci @-@ @ ; p = @ ) .", "no patient in either treatment group experienced asymptomatic genital viral shedding at delivery .", "no neonate had evidence of herpes infection or adverse effects from acyclovir .", "suppressive acyclovir therapy reduced the need for cesarean for recurrent herpes in women whose first clinical episode of genital hsv occurred during pregnancy .", "suppressive acyclovir treatment did not increase asymptomatic viral shedding and was not harmful to the term fetus ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
1,458,072
to compare the tolerance , efficacy , and pharmacokinetics of amphotericin deoxycholate ( fungizone ) prepared in a parenteral fat emulsion ( intralipid @ % ) or glucose in hiv patients with candidiasis . non-blind randomised controlled trial . university hospital ; tertiary clinical care . @ hiv positive patients with oral candidiasis . amphotericin @ mg/kg/day given on four consecutive days as a one hour infusion dissolved in either @ % glucose ( amphotericin-glucose ) or parenteral fat emulsion at a final concentration of @ g/l fat emulsion ( amphotericin-fat emulsion ) . clinical tolerance ( fever , chills , sweats , nausea , arterial pressure , and pulse rate ) ; biological tolerance ( serum creatinine , electrolyte , and magnesium values ) ; clinical score of candidiasis ; and serum concentrations of amphotericin . @ patients were enrolled in each group . all the amphotericin-fat emulsion infusions were given without serious problem whereas four amphotericin-glucose infusions were stopped because of renal impairment ( n = @ ) or severe chills ( n = @ ) , or both . for patients completing the amphotericin-glucose treatment creatine concentration increased by @ mumol/l ; four of seven patients had at least one creatinine value > or = @ mumol/l versus one of @ receiving amphotericin-fat emulsion . magnesium concentration fell significantly with amphotericin-glucose but not with amphotericin-fat emulsion . clinical side effects were noted in @/@ infusions with amphotericin-glucose but @/@ with amphotericin-fat emulsion . oral candidiasis score was reduced similarly in both groups . serum amphotericin concentrations were significantly lower and the volume of distribution of the drug higher after infusion of amphotericin-fat emulsion than after amphotericin-glucose . clinical and renal toxicity of amphotericin are reduced when the drug is prepared in fat emulsion . preparation is simple and cost effective . its efficacy is similar to that of conventional amphotericin .
[ "to compare the tolerance , efficacy , and pharmacokinetics of amphotericin deoxycholate ( fungizone ) prepared in a parenteral fat emulsion ( intralipid @ % ) or glucose in hiv patients with candidiasis .", "non-blind randomised controlled trial .", "university hospital ; tertiary clinical care .", "@ hiv positive patients with oral candidiasis .", "amphotericin @ mg/kg/day given on four consecutive days as a one hour infusion dissolved in either @ % glucose ( amphotericin-glucose ) or parenteral fat emulsion at a final concentration of @ g/l fat emulsion ( amphotericin-fat emulsion ) .", "clinical tolerance ( fever , chills , sweats , nausea , arterial pressure , and pulse rate ) ; biological tolerance ( serum creatinine , electrolyte , and magnesium values ) ; clinical score of candidiasis ; and serum concentrations of amphotericin .", "@ patients were enrolled in each group .", "all the amphotericin-fat emulsion infusions were given without serious problem whereas four amphotericin-glucose infusions were stopped because of renal impairment ( n = @ ) or severe chills ( n = @ ) , or both .", "for patients completing the amphotericin-glucose treatment creatine concentration increased by @ mumol/l ; four of seven patients had at least one creatinine value > or = @ mumol/l versus one of @ receiving amphotericin-fat emulsion .", "magnesium concentration fell significantly with amphotericin-glucose but not with amphotericin-fat emulsion .", "clinical side effects were noted in @/@ infusions with amphotericin-glucose but @/@ with amphotericin-fat emulsion .", "oral candidiasis score was reduced similarly in both groups .", "serum amphotericin concentrations were significantly lower and the volume of distribution of the drug higher after infusion of amphotericin-fat emulsion than after amphotericin-glucose .", "clinical and renal toxicity of amphotericin are reduced when the drug is prepared in fat emulsion .", "preparation is simple and cost effective .", "its efficacy is similar to that of conventional amphotericin ." ]
[ "OBJECTIVE", "OBJECTIVE", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
24,135,831
rate control of atrial fibrillation ( af ) has become a main treatment modality , but we need more knowledge regarding the different drugs used for this purpose . in this study , we aimed to compare the effect of four common rate-reducing drugs on exercise capacity and levels of n-terminal pro-b-type natriuretic peptide ( nt-probnp ) in patients with permanent af . we included @ patients ( mean age @ @ years , @ women ) with permanent af and normal left ventricular function in a randomized , cross-over , investigator-blind study . diltiazem @ mg , verapamil @ mg , metoprolol @ mg , and carvedilol @ mg were administered o.d. for @ weeks . at baseline and on the last day of each treatment period , the patients underwent a maximal cardiopulmonary exercise test and blood samples were obtained at rest and at peak exercise . the exercise capacity ( peak vo@ ) was significantly lower during treatment with metoprolol and carvedilol compared with baseline ( no treatment ) or treatment with diltiazem and verapamil ( p < @ for all ) . compared with baseline , treatment with diltiazem and verapamil significantly reduced the nt-probnp levels both at rest and at peak exercise , whereas treatment with metoprolol and carvedilol increased the levels ( p < @ for all ) . rate-reducing treatment with diltiazem or verapamil preserved exercise capacity and reduced levels of nt-probnp compared with baseline , whereas treatment with metoprolol or carvedilol reduced the exercise capacity and increased levels of nt-probnp .
[ "rate control of atrial fibrillation ( af ) has become a main treatment modality , but we need more knowledge regarding the different drugs used for this purpose .", "in this study , we aimed to compare the effect of four common rate-reducing drugs on exercise capacity and levels of n-terminal pro-b-type natriuretic peptide ( nt-probnp ) in patients with permanent af .", "we included @ patients ( mean age @ @ years , @ women ) with permanent af and normal left ventricular function in a randomized , cross-over , investigator-blind study .", "diltiazem @ mg , verapamil @ mg , metoprolol @ mg , and carvedilol @ mg were administered o.d. for @ weeks .", "at baseline and on the last day of each treatment period , the patients underwent a maximal cardiopulmonary exercise test and blood samples were obtained at rest and at peak exercise .", "the exercise capacity ( peak vo@ ) was significantly lower during treatment with metoprolol and carvedilol compared with baseline ( no treatment ) or treatment with diltiazem and verapamil ( p < @ for all ) .", "compared with baseline , treatment with diltiazem and verapamil significantly reduced the nt-probnp levels both at rest and at peak exercise , whereas treatment with metoprolol and carvedilol increased the levels ( p < @ for all ) .", "rate-reducing treatment with diltiazem or verapamil preserved exercise capacity and reduced levels of nt-probnp compared with baseline , whereas treatment with metoprolol or carvedilol reduced the exercise capacity and increased levels of nt-probnp ." ]
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
11,467,142
post-exposure prophylaxis for rabies with cell culture vaccines by the conventional intramuscular regimen is very expensive . the world health organization has advocated two cost-effective intradermal regimens with cell culture vaccines for use in developing countries . we evaluated these two regimens -- the @-site and the @-site regimens -- in terms of immunogenicity , safety and tolerance in people with category i exposure to rabies . eighty-two subjects who had mild category i exposure to rabies were immunized using a purified chick embryo cell vaccine . the first regimen given to @ subjects , consisted of intradermal administration of @ ml of vaccine at @ sites on days @ , @ and @ and at one site on days @ and @ . the second regimen , given to @ subjects , consisted of intradermal administration of @ ml of vaccine at @ sites on day @ , at @ sites on day @ and at one site on days @ and @ . the mouse neutralization test was used to estimate titres of rabies neutralizing antibody in these subjects on different days after vaccination . the subjects were followed up for @ year . both regimens produced adequate neutralizing antibody titres from day @ onwards , though the second regimen produced a more rapid antibody response and significantly higher titres ( p < @ ) on all days tested . there were minimal side-effects and both regimens were well tolerated . both the @-site and @-site intradermal regimens with purified chick embryo cell vaccine produce adequate levels of neutralizing antibodies but the @-site regimen appears to be more immunogenic . the feasibility of using these cost-effective regimens in routine practice needs to be further evaluated under the field conditions prevalent in india .
[ "post-exposure prophylaxis for rabies with cell culture vaccines by the conventional intramuscular regimen is very expensive .", "the world health organization has advocated two cost-effective intradermal regimens with cell culture vaccines for use in developing countries .", "we evaluated these two regimens -- the @-site and the @-site regimens -- in terms of immunogenicity , safety and tolerance in people with category i exposure to rabies .", "eighty-two subjects who had mild category i exposure to rabies were immunized using a purified chick embryo cell vaccine .", "the first regimen given to @ subjects , consisted of intradermal administration of @ ml of vaccine at @ sites on days @ , @ and @ and at one site on days @ and @ .", "the second regimen , given to @ subjects , consisted of intradermal administration of @ ml of vaccine at @ sites on day @ , at @ sites on day @ and at one site on days @ and @ .", "the mouse neutralization test was used to estimate titres of rabies neutralizing antibody in these subjects on different days after vaccination .", "the subjects were followed up for @ year .", "both regimens produced adequate neutralizing antibody titres from day @ onwards , though the second regimen produced a more rapid antibody response and significantly higher titres ( p < @ ) on all days tested .", "there were minimal side-effects and both regimens were well tolerated .", "both the @-site and @-site intradermal regimens with purified chick embryo cell vaccine produce adequate levels of neutralizing antibodies but the @-site regimen appears to be more immunogenic .", "the feasibility of using these cost-effective regimens in routine practice needs to be further evaluated under the field conditions prevalent in india ." ]
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
21,766,893
discrete-choice experiments are based on the premise that any good or service can be described by its characteristics ( or attributes ) , and the extent to which an individual values a good or service depends on the levels of these characteristics . little is known about patient preferences for treatment of chronic musculoskeletal pain such as achilles tendinopathy . a discrete-choice experiment was conducted in @ adults with a history of achilles tendon pain at the conclusion of a three-arm randomized clinical trial . participants were asked to complete a questionnaire consisting of ten hypothetical treatment scenarios and some sociodemographic questions . for each scenario , participants were asked to choose which option they would prefer if seeking treatment for their painful achilles tendon . a mixed logit model was estimated to quantify subject preferences and marginal willingness to pay for the treatment attributes . a response rate of @ % was achieved . a significant positive impact on utility was observed for chance of treatment success . a significant negative impact on utility was observed for cost , weeks before exercise can be completed free of pain , chance of side effects ( p = @ ) , and injections as a stand-alone treatment . respondents were willing to pay australian dollars ( $ a ) @ ( @ % ci -@ , @ ) for a @ % increase in the chance of treatment success . study participants with achilles tendon pain who had either participated or expressed an interest in participating in a randomized trial prefer a treatment that costs less , has a greater chance of success , has a shorter duration before being able to exercise free of pain , and has less likelihood of side effects . on average , participants preferred exercises over injections as a stand-alone treatment . further research is required to confirm the findings in patients outside of the trial setting . nevertheless , this study contributes to an area that is deficient in research by identifying priorities and marginal willingness to pay for attributes related to achilles tendinopathy .
[ "discrete-choice experiments are based on the premise that any good or service can be described by its characteristics ( or attributes ) , and the extent to which an individual values a good or service depends on the levels of these characteristics .", "little is known about patient preferences for treatment of chronic musculoskeletal pain such as achilles tendinopathy .", "a discrete-choice experiment was conducted in @ adults with a history of achilles tendon pain at the conclusion of a three-arm randomized clinical trial .", "participants were asked to complete a questionnaire consisting of ten hypothetical treatment scenarios and some sociodemographic questions .", "for each scenario , participants were asked to choose which option they would prefer if seeking treatment for their painful achilles tendon .", "a mixed logit model was estimated to quantify subject preferences and marginal willingness to pay for the treatment attributes .", "a response rate of @ % was achieved .", "a significant positive impact on utility was observed for chance of treatment success .", "a significant negative impact on utility was observed for cost , weeks before exercise can be completed free of pain , chance of side effects ( p = @ ) , and injections as a stand-alone treatment .", "respondents were willing to pay australian dollars ( $ a ) @ ( @ % ci -@ , @ ) for a @ % increase in the chance of treatment success .", "study participants with achilles tendon pain who had either participated or expressed an interest in participating in a randomized trial prefer a treatment that costs less , has a greater chance of success , has a shorter duration before being able to exercise free of pain , and has less likelihood of side effects .", "on average , participants preferred exercises over injections as a stand-alone treatment .", "further research is required to confirm the findings in patients outside of the trial setting .", "nevertheless , this study contributes to an area that is deficient in research by identifying priorities and marginal willingness to pay for attributes related to achilles tendinopathy ." ]
[ "OBJECTIVE", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
24,816,809
whether prasugrel plus bivalirudin is a superior strategy to unfractionated heparin plus clopidogrel in patients with st-segment elevation myocardial infarction ( stemi ) undergoing primary percutaneous coronary intervention ( pci ) has never been assessed in specifically designed randomized trials . the bavarian reperfusion alternatives evaluation ( brave ) @ study is an investigator-initiated , randomized , open-label , multicentre trial , designed to test the hypothesis that in stemi patients with planned primary pci a strategy based on prasugrel plus bivalirudin is superior to a strategy based on clopidogrel plus heparin in terms of net clinical outcome . owing to slow recruitment , the trial was stopped prematurely after enrolment of @ of @ planned patients . at @ days , the primary composite endpoint of death , myocardial infarction , unplanned revascularization of the infarct related artery , stent thrombosis , stroke , or bleeding was observed in @ patients ( @ % ) randomized to prasugrel plus bivalirudin and @ patients ( @ % ) randomized to clopidogrel plus heparin [ relative risk , @ ; one-sided @ % confidence interval ( ci ) @-@ @ , p = @ ] . the composite ischaemic endpoint of death , myocardial infarction , unplanned revascularization of the infarct-related artery , stent thrombosis , or stroke occurred in @ patients ( @ % ) in the prasugrel plus bivalirudin group and @ patients ( @ % ) in the clopidogrel plus heparin group ( relative risk , @ ; @ % ci @-@ @ , p = @ ) . bleeding according to the horizons-ami definition was observed in @ patients ( @ % ) in the prasugrel plus bivalirudin group and @ patients ( @ % ) in the clopidogrel plus heparin group ( relative risk , @ ; @ % ci @-@ @ , p = @ ) . results were consistent across various subgroups of patients . in this randomized trial of stemi patients , we were unable to demonstrate significant differences in net clinical outcome between prasugrel plus bivalirudin and clopidogrel plus heparin . neither the composite of ischaemic complications nor bleeding were favourably affected by prasugrel plus bivalirudin compared with a regimen of clopidogrel plus unfractionated heparin . however , the results must be interpreted in view of the premature termination of the trial . unique identifier nct@ ( www.clinicaltrials.gov ) .
[ "whether prasugrel plus bivalirudin is a superior strategy to unfractionated heparin plus clopidogrel in patients with st-segment elevation myocardial infarction ( stemi ) undergoing primary percutaneous coronary intervention ( pci ) has never been assessed in specifically designed randomized trials .", "the bavarian reperfusion alternatives evaluation ( brave ) @ study is an investigator-initiated , randomized , open-label , multicentre trial , designed to test the hypothesis that in stemi patients with planned primary pci a strategy based on prasugrel plus bivalirudin is superior to a strategy based on clopidogrel plus heparin in terms of net clinical outcome .", "owing to slow recruitment , the trial was stopped prematurely after enrolment of @ of @ planned patients .", "at @ days , the primary composite endpoint of death , myocardial infarction , unplanned revascularization of the infarct related artery , stent thrombosis , stroke , or bleeding was observed in @ patients ( @ % ) randomized to prasugrel plus bivalirudin and @ patients ( @ % ) randomized to clopidogrel plus heparin [ relative risk , @ ; one-sided @ % confidence interval ( ci ) @-@ @ , p = @ ] .", "the composite ischaemic endpoint of death , myocardial infarction , unplanned revascularization of the infarct-related artery , stent thrombosis , or stroke occurred in @ patients ( @ % ) in the prasugrel plus bivalirudin group and @ patients ( @ % ) in the clopidogrel plus heparin group ( relative risk , @ ; @ % ci @-@ @ , p = @ ) .", "bleeding according to the horizons-ami definition was observed in @ patients ( @ % ) in the prasugrel plus bivalirudin group and @ patients ( @ % ) in the clopidogrel plus heparin group ( relative risk , @ ; @ % ci @-@ @ , p = @ ) .", "results were consistent across various subgroups of patients .", "in this randomized trial of stemi patients , we were unable to demonstrate significant differences in net clinical outcome between prasugrel plus bivalirudin and clopidogrel plus heparin .", "neither the composite of ischaemic complications nor bleeding were favourably affected by prasugrel plus bivalirudin compared with a regimen of clopidogrel plus unfractionated heparin .", "however , the results must be interpreted in view of the premature termination of the trial .", "unique identifier nct@ ( www.clinicaltrials.gov ) ." ]
[ "OBJECTIVE", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
12,551,795
to evaluate the long-term recurrence rates and complication of different techniques of cervical ablation . a randomized trial of three techniques of conization ( cold knife , laser , and loop electrosurgical excisional procedure ( leep ) ) for cervical intraepithelial neoplasia ( cin ) in which @ patients had been recruited . eighty-six patients were followed-up for more than @ years . of these @ had been treated with the cold knife , @ with leep and @ by laser . five recurrences were observed , one in the cold knife group , two in the leep group and two in the laser group ( p = ns ) . the only observed complication was cervical stenosis : zero cases in the laser group , one case in the leep group and four cases in the cold knife group ( laser versus cold knife : p = @ ; leep versus cold knife : p = @ ) . fifty pregnancies were observed in @ patients . first and second trimester outcomes of pregnancy were without complications . one patient treated with the leep presented with a premature rupture of membranes and premature labor at @ weeks . a total of nine cesarean sections were performed with two cases for cervical dystocia . there is no major difference in obstetrical outcome between the three techniques .
[ "to evaluate the long-term recurrence rates and complication of different techniques of cervical ablation .", "a randomized trial of three techniques of conization ( cold knife , laser , and loop electrosurgical excisional procedure ( leep ) ) for cervical intraepithelial neoplasia ( cin ) in which @ patients had been recruited .", "eighty-six patients were followed-up for more than @ years .", "of these @ had been treated with the cold knife , @ with leep and @ by laser .", "five recurrences were observed , one in the cold knife group , two in the leep group and two in the laser group ( p = ns ) .", "the only observed complication was cervical stenosis : zero cases in the laser group , one case in the leep group and four cases in the cold knife group ( laser versus cold knife : p = @ ; leep versus cold knife : p = @ ) .", "fifty pregnancies were observed in @ patients .", "first and second trimester outcomes of pregnancy were without complications .", "one patient treated with the leep presented with a premature rupture of membranes and premature labor at @ weeks .", "a total of nine cesarean sections were performed with two cases for cervical dystocia .", "there is no major difference in obstetrical outcome between the three techniques ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
15,897,479
to determine whether macronutrient composition of a hypocaloric diet can enhance its effectiveness and whether insulin sensitivity ( si ) affects the response to hypocaloric diets . obese nondiabetic insulin-sensitive ( fasting insulin < @ microu/ml ; n = @ ) and obese nondiabetic insulin-resistant ( fasting insulin > @ microu/ml ; n = @ ) women ( @ to @ years old ) were randomized to either a high carbohydrate ( cho ) ( hc ) / low fat ( lf ) ( @ % cho , @ % fat ) or low cho ( lc ) / high fat ( hf ) ( @ % cho , @ % fat ) hypocaloric diet . primary outcome measures after a @-week dietary intervention were : changes in body weight ( bw ) , si , resting metabolic rate , and fasting lipids . insulin-sensitive women on the hc/lf diet lost @ + / - @ % ( p < @ ) of their initial bw , whereas those on the lc/hf diet lost @ + / - @ % ( p < @ ; p < @ between the groups ) . in contrast , among the insulin-resistant women , those on the lc/hf diet lost @ + / - @ % ( p < @ ) of their initial bw as compared with @ + / - @ % ( p < @ ) lost by those on the hc/lf diet ( p < @ between two groups ) . these differences could not be explained by changes in resting metabolic rate , activity , or intake . overall , changes in si were associated with the degree of weight loss ( r = -@ , p < @ ) . the state of si determines the effectiveness of macronutrient composition of hypocaloric diets in obese women . for maximal benefit , the macronutrient composition of a hypocaloric diet may need to be adjusted to correspond to the state of si .
[ "to determine whether macronutrient composition of a hypocaloric diet can enhance its effectiveness and whether insulin sensitivity ( si ) affects the response to hypocaloric diets .", "obese nondiabetic insulin-sensitive ( fasting insulin < @ microu/ml ; n = @ ) and obese nondiabetic insulin-resistant ( fasting insulin > @ microu/ml ; n = @ ) women ( @ to @ years old ) were randomized to either a high carbohydrate ( cho ) ( hc ) / low fat ( lf ) ( @ % cho , @ % fat ) or low cho ( lc ) / high fat ( hf ) ( @ % cho , @ % fat ) hypocaloric diet .", "primary outcome measures after a @-week dietary intervention were : changes in body weight ( bw ) , si , resting metabolic rate , and fasting lipids .", "insulin-sensitive women on the hc/lf diet lost @ + / - @ % ( p < @ ) of their initial bw , whereas those on the lc/hf diet lost @ + / - @ % ( p < @ ; p < @ between the groups ) .", "in contrast , among the insulin-resistant women , those on the lc/hf diet lost @ + / - @ % ( p < @ ) of their initial bw as compared with @ + / - @ % ( p < @ ) lost by those on the hc/lf diet ( p < @ between two groups ) .", "these differences could not be explained by changes in resting metabolic rate , activity , or intake .", "overall , changes in si were associated with the degree of weight loss ( r = -@ , p < @ ) .", "the state of si determines the effectiveness of macronutrient composition of hypocaloric diets in obese women .", "for maximal benefit , the macronutrient composition of a hypocaloric diet may need to be adjusted to correspond to the state of si ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
8,182,401
to compare the effects of dry needling of myofascial trigger points in the neck region to metoprolol in migraine prophylaxis . randomized , group comparative study . patients , investigator and statistician were blinded as to treatment , the therapist was blinded as to results . outpatient pain clinic in the northern copenhagen area . patients were referred by general practitioners or respondents to newspaper advertisements . included were patients with a history of migraine with or without aura for at least @ years . excluded were persons with contraindications against treatment with beta blockers , chronic pain syndromes , pregnancy or previous experience with acupuncture or beta-blocking agents . a total of @ patients were included ; @ completed the study . after a @-week run-in period , patients were allocated to a @-week regimen either with acupuncture and placebo tablets or to placebo stimulation and metoprolol @ mg daily . both groups exhibited significant reduction in attack frequency ( p < @ ) . no difference was found between the groups regarding frequency ( p > @ ) or duration ( p > @ ) of attacks , whereas we found a significant difference in global rating of attacks in favour of metoprolol ( p < @ ) . trigger point inactivation by dry needling is a valuable supplement to the list of migraine prophylactic tools , being equipotent to metoprolol in the influence on frequency and duration ( but not severity ) of attacks , and superior in terms of negative side-effects .
[ "to compare the effects of dry needling of myofascial trigger points in the neck region to metoprolol in migraine prophylaxis .", "randomized , group comparative study .", "patients , investigator and statistician were blinded as to treatment , the therapist was blinded as to results .", "outpatient pain clinic in the northern copenhagen area .", "patients were referred by general practitioners or respondents to newspaper advertisements .", "included were patients with a history of migraine with or without aura for at least @ years .", "excluded were persons with contraindications against treatment with beta blockers , chronic pain syndromes , pregnancy or previous experience with acupuncture or beta-blocking agents .", "a total of @ patients were included ; @ completed the study .", "after a @-week run-in period , patients were allocated to a @-week regimen either with acupuncture and placebo tablets or to placebo stimulation and metoprolol @ mg daily .", "both groups exhibited significant reduction in attack frequency ( p < @ ) .", "no difference was found between the groups regarding frequency ( p > @ ) or duration ( p > @ ) of attacks , whereas we found a significant difference in global rating of attacks in favour of metoprolol ( p < @ ) .", "trigger point inactivation by dry needling is a valuable supplement to the list of migraine prophylactic tools , being equipotent to metoprolol in the influence on frequency and duration ( but not severity ) of attacks , and superior in terms of negative side-effects ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
17,217,318
this study aimed to evaluate the effects of monophasic estrogen-progestogen therapy on the sexuality and climacteric symptoms of postmenopausal women . a prospective , randomised , double-blind , crossover , placebo-controlled , single-centre study was carried out over a total of @ consecutive months in @ postmenopausal women with an intact uterus who had no contraindications to hormone therapy . patients received @beta-estradiol @mg in combination with norethisterone acetate @mg ( cliane ) daily for @ months or one placebo tablet daily for @ months . the tablets were identical in appearance . after @ months , the groups were crossed over and the patients were followed up for another @ months . the groups were homogenous with respect to age , height , bodyweight , body mass index and race . for the statistical analysis , the group receiving hormone therapy was referred to as group a and the placebo group was designated group b , irrespective of the placebo/hormone therapy sequence . in group a there were fewer hot flashes ( f = @ , p < @ ) and an improvement in sexual interest ( f = @ , p < @ ) . the sequence in which the medication was received resulted in a statistically significant difference with respect to dyspareunia ( f = @ , p < @ ) and satisfaction with the duration of penetration ( f = @ , p < @ ) . in the intrapatient analysis of variation with respect to orgasmic capability and the presence of dialogue with partner regarding the couple 's sexual life , whether the placebo was taken prior to or following hormone therapy was significant ( f = @ , p < @ and f = @ , p < @ , respectively ) . monophasic estrogen-progestogen therapy has a beneficial effect on sexuality and on hot flashes in postmenopausal women .
[ "this study aimed to evaluate the effects of monophasic estrogen-progestogen therapy on the sexuality and climacteric symptoms of postmenopausal women .", "a prospective , randomised , double-blind , crossover , placebo-controlled , single-centre study was carried out over a total of @ consecutive months in @ postmenopausal women with an intact uterus who had no contraindications to hormone therapy .", "patients received @beta-estradiol @mg in combination with norethisterone acetate @mg ( cliane ) daily for @ months or one placebo tablet daily for @ months .", "the tablets were identical in appearance .", "after @ months , the groups were crossed over and the patients were followed up for another @ months .", "the groups were homogenous with respect to age , height , bodyweight , body mass index and race .", "for the statistical analysis , the group receiving hormone therapy was referred to as group a and the placebo group was designated group b , irrespective of the placebo/hormone therapy sequence .", "in group a there were fewer hot flashes ( f = @ , p < @ ) and an improvement in sexual interest ( f = @ , p < @ ) .", "the sequence in which the medication was received resulted in a statistically significant difference with respect to dyspareunia ( f = @ , p < @ ) and satisfaction with the duration of penetration ( f = @ , p < @ ) .", "in the intrapatient analysis of variation with respect to orgasmic capability and the presence of dialogue with partner regarding the couple 's sexual life , whether the placebo was taken prior to or following hormone therapy was significant ( f = @ , p < @ and f = @ , p < @ , respectively ) .", "monophasic estrogen-progestogen therapy has a beneficial effect on sexuality and on hot flashes in postmenopausal women ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
19,852,282
to investigate the clinical effect of the chinese medicinal preparation shengling capsule on patients with oligoasthenospermia . a total of @ male patients with infertility induced by oligoasthenospermia were equally divided into a treatment and a control group , the former medicated with shengling capsule at the dose of @ g tid , and the latter given vit e at @ mg tid , both for a course of @ weeks . then we analyzed the changes in the patients ` seminal parameters and the pregnancy of their wives . after @ weeks of medication , both the seminal parameters of the patients and pregnancy of their wives were remarkably improved , with extremely significant differences from pre-treatment and the control ( p < @ ) . shengjing capsule can improve sperm motility and vitality as well as sperm count . with few adverse effects , it can be used as a safe and effective therapeutic for male infertility induced by oligoasthenospermia .
[ "to investigate the clinical effect of the chinese medicinal preparation shengling capsule on patients with oligoasthenospermia .", "a total of @ male patients with infertility induced by oligoasthenospermia were equally divided into a treatment and a control group , the former medicated with shengling capsule at the dose of @ g tid , and the latter given vit e at @ mg tid , both for a course of @ weeks .", "then we analyzed the changes in the patients ` seminal parameters and the pregnancy of their wives .", "after @ weeks of medication , both the seminal parameters of the patients and pregnancy of their wives were remarkably improved , with extremely significant differences from pre-treatment and the control ( p < @ ) .", "shengjing capsule can improve sperm motility and vitality as well as sperm count .", "with few adverse effects , it can be used as a safe and effective therapeutic for male infertility induced by oligoasthenospermia ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
9,072,052
to assess the usefulness of helisal in the diagnosis of helicobacter pylori infection by comparing it with elisa , jatrox and histopathologic findings . randomized prospective study . sixty-one patients , thirty-three males and twenty-eight females , @-@ years old , submitted to esophagogastroduodenoscopy . the sensitivity of helisal when compared to elisa test was @ % , the specificity @ % , the positive predictive value @ % , the negative predictive value @ % , and the kappa index @ . when compared to histopathologic test : sensitivity @ % , specificity @ % , positive predictive value @ % , negative predictive value @ % , kappa @ . when compared to jatrox , sensitivity @ % , specificity @ % , positive predictive value @ % , negative predictive value @ % , kappa @ . the sensitivity of helisal test is lower than that of other compared tests , and the negative predictive value is very low . the specificity and the positive predictive value are higher than the sensitivity . the kappa index shows a very low concordance .
[ "to assess the usefulness of helisal in the diagnosis of helicobacter pylori infection by comparing it with elisa , jatrox and histopathologic findings .", "randomized prospective study .", "sixty-one patients , thirty-three males and twenty-eight females , @-@ years old , submitted to esophagogastroduodenoscopy .", "the sensitivity of helisal when compared to elisa test was @ % , the specificity @ % , the positive predictive value @ % , the negative predictive value @ % , and the kappa index @ .", "when compared to histopathologic test : sensitivity @ % , specificity @ % , positive predictive value @ % , negative predictive value @ % , kappa @ .", "when compared to jatrox , sensitivity @ % , specificity @ % , positive predictive value @ % , negative predictive value @ % , kappa @ .", "the sensitivity of helisal test is lower than that of other compared tests , and the negative predictive value is very low .", "the specificity and the positive predictive value are higher than the sensitivity .", "the kappa index shows a very low concordance ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
10,510,951
to evaluate the effects of simvastatin on serum lipids and insulin sensitivity in type @ diabetic patients with hypercholesterolaemia . a double-blind , randomized , placebo-controlled and two-period crossover study . after a @-month run-in , @ eligible type @ diabetic patients with hypercholesterolaemia were randomized to receive either simvastatin or placebo for @ months , exchanging their treatment thereafter for another @ months . blood samples were taken in month @ and at monthly intervals to measure serum lipids and indices of glycaemic control . an euglycaemic insulin clamp was performed in months @ , @ and @ to assess change of insulin sensitivity . the amount of glucose infused during @-@ min of the clamp ( m ) , and the mean values of serum insulin during @-@ min ( i ) were measured . the m and m/i ratio were used to represent the in vivo insulin sensitivity of the subject . simvastatin significantly reduced serum total cholesterol ( tc ) by @ + / -@ % and low density lipoprotein-cholesterol ( ldl-c ) by @ + / -@ % . it did not alter glycaemic control . the m-values and m/i ratios were similar in both groups in each period and no drug effect on insulin sensitivity could be identified . simvastatin significantly reduced the serum tc and ldl-c levels without alteration of insulin sensitivity in type @ diabetic patients with hypercholesterolaemia .
[ "to evaluate the effects of simvastatin on serum lipids and insulin sensitivity in type @ diabetic patients with hypercholesterolaemia .", "a double-blind , randomized , placebo-controlled and two-period crossover study .", "after a @-month run-in , @ eligible type @ diabetic patients with hypercholesterolaemia were randomized to receive either simvastatin or placebo for @ months , exchanging their treatment thereafter for another @ months .", "blood samples were taken in month @ and at monthly intervals to measure serum lipids and indices of glycaemic control .", "an euglycaemic insulin clamp was performed in months @ , @ and @ to assess change of insulin sensitivity .", "the amount of glucose infused during @-@ min of the clamp ( m ) , and the mean values of serum insulin during @-@ min ( i ) were measured .", "the m and m/i ratio were used to represent the in vivo insulin sensitivity of the subject .", "simvastatin significantly reduced serum total cholesterol ( tc ) by @ + / -@ % and low density lipoprotein-cholesterol ( ldl-c ) by @ + / -@ % .", "it did not alter glycaemic control .", "the m-values and m/i ratios were similar in both groups in each period and no drug effect on insulin sensitivity could be identified .", "simvastatin significantly reduced the serum tc and ldl-c levels without alteration of insulin sensitivity in type @ diabetic patients with hypercholesterolaemia ." ]
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
10,871,561
premenopausal african american women have a @-@ times greater incidence of coronary heart disease ( chd ) than do white women . the plasma lipid responsiveness to dietary fat , which may be associated with chd , has not been adequately studied in premenopausal african american or white women . the objective of our study was to compare the effect of diet on fasting plasma lipids and lipoproteins and postprandial lipemia in premenopausal african american and white women . thirteen african american and @ white healthy premenopausal women were fed a low-fat , high-fiber diet and a high-fat , low-fiber diet for @ wk each in a randomized crossover design . fasting plasma lipid and lipoprotein concentrations and the @-h plasma triacylglycerol response to a standard fatty test meal were measured at the end of each dietary period . plasma total and ldl-cholesterol concentrations were higher after the high-fat , low-fiber diet in both white and african american women ( p < @ ) . the @-h area under the plasma triacylglycerol curve after the test meal was lower after the low-fat diet than after the high-fat diet ( p < @ ) . african american and white women had lower fasting plasma total and ldl-cholesterol concentrations and less postprandial lipemia after the low-fat than the high-fat diet . diets low in total and saturated fat and cholesterol and high in fiber may reduce the risk of chd by lowering fasting plasma total and ldl-cholesterol concentrations and by reducing the lipemic response to fatty meals .
[ "premenopausal african american women have a @-@ times greater incidence of coronary heart disease ( chd ) than do white women .", "the plasma lipid responsiveness to dietary fat , which may be associated with chd , has not been adequately studied in premenopausal african american or white women .", "the objective of our study was to compare the effect of diet on fasting plasma lipids and lipoproteins and postprandial lipemia in premenopausal african american and white women .", "thirteen african american and @ white healthy premenopausal women were fed a low-fat , high-fiber diet and a high-fat , low-fiber diet for @ wk each in a randomized crossover design .", "fasting plasma lipid and lipoprotein concentrations and the @-h plasma triacylglycerol response to a standard fatty test meal were measured at the end of each dietary period .", "plasma total and ldl-cholesterol concentrations were higher after the high-fat , low-fiber diet in both white and african american women ( p < @ ) .", "the @-h area under the plasma triacylglycerol curve after the test meal was lower after the low-fat diet than after the high-fat diet ( p < @ ) .", "african american and white women had lower fasting plasma total and ldl-cholesterol concentrations and less postprandial lipemia after the low-fat than the high-fat diet .", "diets low in total and saturated fat and cholesterol and high in fiber may reduce the risk of chd by lowering fasting plasma total and ldl-cholesterol concentrations and by reducing the lipemic response to fatty meals ." ]
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
23,497,763
mirabegron is a @-adrenoceptor agonist used for the treatment of overactive bladder . mirabegron is formulated as an extended-release tablet using oral controlled-absorption system ( ocas ) technology . this study was designed to assess the effects of food on the pharmacokinetic properties of mirabegron ocas in accordance with regulatory requirements to support dosing recommendations . in this single-dose , randomized , open-label , @-period , parallel-dose-group , crossover study , mirabegron ocas @ or @ mg was administered orally to healthy adult subjects in the fasted state or after a high - or low-fat breakfast . dose administrations were separated by a washout period of at least @ days . blood samples were drawn up to @ hours after dosing , and plasma concentrations of mirabegron were analyzed by lc/ms-ms . pk properties were determined using noncompartmental methods . primary end points for the assessment of food effects were cmax and auc@ - . for tolerability assessment , adverse events ( aes ) were monitored using investigators ' questionnaires and subjects ' spontaneous reports , vital sign measurements , hematology , clinical chemistry , and ecg . thirty-eight subjects ( male , @ % ; mean age , @ years ; mean weight , @ kg ; race , @ % white ) were enrolled in the @-mg dose group and @ subjects ( male , @ % ; mean age , @ years ; mean weight , @ kg ; race , @ % white ) in the @-mg dose group . with either fed condition or dose , the @ % cis for the fed/fasted ratios of both cmax and auc@ - of mirabegron fell below the predetermined range for bioequivalence ( @ % -@ % ) , suggesting that food had no effect on exposure to mirabegron ocas . with the @-mg dose , mirabegron cmax was reduced by @ % with a high-fat breakfast compared with fasted conditions ( geometric mean ratio [ gmr ] , @ % [ @ % ci , @ % -@ % ] ) and auc@ - , by @ % ( gmr , @ % [ @ % ci , @ % -@ % ] ) . with the @-mg dose , mirabegron cmax and auc@ - were reduced by @ % ( gmr , @ % [ @ % ci , @ % -@ % ] ) and @ % ( @ % [ @ % -@ % ] ) , respectively , after a high-fat breakfast . with the @-mg dose , mirabegron cmax was decreased by @ % ( gmr , @ % [ @ % ci , @ % -@ % ] ) and auc@ - by @ % ( @ % [ @ % -@ % ] ) after a low-fat breakfast . corresponding reductions with the @-mg dose were @ % ( gmr , @ % [ @ % ci , @ % -@ % ] ) for cmax and @ % ( gmr , @ % [ @ % ci , @ % -@ % ] ) for auc@ - . the fed/fasted ratios for mirabegron cmax and auc@ - were in general independent of dose or sex . food delayed tmax compared with the fasted state , with similar increases with the high - and low-fat meals ( @ hours with @ mg and @-@ @ hours with @ mg ) . mirabegron was generally well tolerated , with no apparent difference in ae frequency between the fasted and fed states . mirabegron ocas tablets exhibited a decrease in mirabegron plasma exposure with food that was independent of dose ( @ or @ mg ) or gender but dependent on meal composition . a greater reduction in mirabegron exposure was observed after a low-fat breakfast compared with after a high-fat breakfast . based on findings from previous studies , the effects of food observed in this study do not warrant dose adjustment in clinical practice . clinicaltrials.gov identifier : nct@ .
[ "mirabegron is a @-adrenoceptor agonist used for the treatment of overactive bladder .", "mirabegron is formulated as an extended-release tablet using oral controlled-absorption system ( ocas ) technology .", "this study was designed to assess the effects of food on the pharmacokinetic properties of mirabegron ocas in accordance with regulatory requirements to support dosing recommendations .", "in this single-dose , randomized , open-label , @-period , parallel-dose-group , crossover study , mirabegron ocas @ or @ mg was administered orally to healthy adult subjects in the fasted state or after a high - or low-fat breakfast .", "dose administrations were separated by a washout period of at least @ days .", "blood samples were drawn up to @ hours after dosing , and plasma concentrations of mirabegron were analyzed by lc/ms-ms .", "pk properties were determined using noncompartmental methods .", "primary end points for the assessment of food effects were cmax and auc@ - .", "for tolerability assessment , adverse events ( aes ) were monitored using investigators ' questionnaires and subjects ' spontaneous reports , vital sign measurements , hematology , clinical chemistry , and ecg .", "thirty-eight subjects ( male , @ % ; mean age , @ years ; mean weight , @ kg ; race , @ % white ) were enrolled in the @-mg dose group and @ subjects ( male , @ % ; mean age , @ years ; mean weight , @ kg ; race , @ % white ) in the @-mg dose group .", "with either fed condition or dose , the @ % cis for the fed/fasted ratios of both cmax and auc@ - of mirabegron fell below the predetermined range for bioequivalence ( @ % -@ % ) , suggesting that food had no effect on exposure to mirabegron ocas .", "with the @-mg dose , mirabegron cmax was reduced by @ % with a high-fat breakfast compared with fasted conditions ( geometric mean ratio [ gmr ] , @ % [ @ % ci , @ % -@ % ] ) and auc@ - , by @ % ( gmr , @ % [ @ % ci , @ % -@ % ] ) .", "with the @-mg dose , mirabegron cmax and auc@ - were reduced by @ % ( gmr , @ % [ @ % ci , @ % -@ % ] ) and @ % ( @ % [ @ % -@ % ] ) , respectively , after a high-fat breakfast .", "with the @-mg dose , mirabegron cmax was decreased by @ % ( gmr , @ % [ @ % ci , @ % -@ % ] ) and auc@ - by @ % ( @ % [ @ % -@ % ] ) after a low-fat breakfast .", "corresponding reductions with the @-mg dose were @ % ( gmr , @ % [ @ % ci , @ % -@ % ] ) for cmax and @ % ( gmr , @ % [ @ % ci , @ % -@ % ] ) for auc@ - .", "the fed/fasted ratios for mirabegron cmax and auc@ - were in general independent of dose or sex .", "food delayed tmax compared with the fasted state , with similar increases with the high - and low-fat meals ( @ hours with @ mg and @-@ @ hours with @ mg ) .", "mirabegron was generally well tolerated , with no apparent difference in ae frequency between the fasted and fed states .", "mirabegron ocas tablets exhibited a decrease in mirabegron plasma exposure with food that was independent of dose ( @ or @ mg ) or gender but dependent on meal composition .", "a greater reduction in mirabegron exposure was observed after a low-fat breakfast compared with after a high-fat breakfast .", "based on findings from previous studies , the effects of food observed in this study do not warrant dose adjustment in clinical practice .", "clinicaltrials.gov identifier : nct@ ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
16,458,629
the purpose of this study was to determine predictors of worsening insulin sensitivity in postmenopausal women . seventy-one nonobese postmenopausal women were assigned randomly to receive hormone replacement therapy ( conjugated estrogens , @ mg , plus medroxyprogesterone acetate , @ mg ) or placebo daily for @ year ( @ women received hormone replacement therapy , and @ women received placebo ) . at baseline and @ months , the women received a computed tomography scan at the l@-l@ vertebral disk space , a dual x-ray absorptiometry scan , a euglycemic hyperinsulinemic clamp to measure insulin sensitivity , and a lipid profile . declining insulin sensitivity was defined as the largest quartile change in insulin sensitivity in the women who received the placebo ( -@ mg/min/kg lean body mass ) . by univariate analysis , we found that significant predictors of worsening insulin sensitivity were the use of hormone replacement therapy , baseline insulin sensitivity , a younger age , and < @ years since menopause . by logistic regression , we determined that hormone replacement therapy use and higher baseline insulin sensitivity were independent predictors of worsening insulin sensitivity . the use of hormone replacement therapy and baseline insulin sensitivity are significant independent predictors of the development of worsening insulin sensitivity in postmenopausal women .
[ "the purpose of this study was to determine predictors of worsening insulin sensitivity in postmenopausal women .", "seventy-one nonobese postmenopausal women were assigned randomly to receive hormone replacement therapy ( conjugated estrogens , @ mg , plus medroxyprogesterone acetate , @ mg ) or placebo daily for @ year ( @ women received hormone replacement therapy , and @ women received placebo ) .", "at baseline and @ months , the women received a computed tomography scan at the l@-l@ vertebral disk space , a dual x-ray absorptiometry scan , a euglycemic hyperinsulinemic clamp to measure insulin sensitivity , and a lipid profile .", "declining insulin sensitivity was defined as the largest quartile change in insulin sensitivity in the women who received the placebo ( -@ mg/min/kg lean body mass ) .", "by univariate analysis , we found that significant predictors of worsening insulin sensitivity were the use of hormone replacement therapy , baseline insulin sensitivity , a younger age , and < @ years since menopause .", "by logistic regression , we determined that hormone replacement therapy use and higher baseline insulin sensitivity were independent predictors of worsening insulin sensitivity .", "the use of hormone replacement therapy and baseline insulin sensitivity are significant independent predictors of the development of worsening insulin sensitivity in postmenopausal women ." ]
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
24,107,907
ablative surgery of oropharyngeal tumors frequently leads to defects in the speech organs , resulting in impairment of speech up to the point of unintelligibility . the aim of the present study was the assessment of selected parameters of speech with and without resection prostheses . the speech sounds of @ patients suffering from maxillary and mandibular defects were recorded using a digital audio tape ( dat ) recorder with and without resection prostheses . evaluation of the resonance and the production of the sounds / s / , / sch / , and / ch / was performed by @ experienced speech therapists . additionally , the patients completed a non-standardized questionnaire containing a linguistic self-assessment . after prosthesis supply , the number of patients with rhinophonia aperta decreased from @ to @ while the number of patients with intelligible speech increased from @ to @ . correct production of the sounds / s / , / sch / , and / ch / increased from @ to @ patients . a significant improvement of the evaluated parameters could be observed only in patients with maxillary defects . the linguistic self-assessment showed a higher satisfaction in patients with maxillary defects . in patients with maxillary defects due to ablative tumor surgery , an increase in speech performance and intelligibility is possible by supplying resection prostheses .
[ "ablative surgery of oropharyngeal tumors frequently leads to defects in the speech organs , resulting in impairment of speech up to the point of unintelligibility .", "the aim of the present study was the assessment of selected parameters of speech with and without resection prostheses .", "the speech sounds of @ patients suffering from maxillary and mandibular defects were recorded using a digital audio tape ( dat ) recorder with and without resection prostheses .", "evaluation of the resonance and the production of the sounds / s / , / sch / , and / ch / was performed by @ experienced speech therapists .", "additionally , the patients completed a non-standardized questionnaire containing a linguistic self-assessment .", "after prosthesis supply , the number of patients with rhinophonia aperta decreased from @ to @ while the number of patients with intelligible speech increased from @ to @ .", "correct production of the sounds / s / , / sch / , and / ch / increased from @ to @ patients .", "a significant improvement of the evaluated parameters could be observed only in patients with maxillary defects .", "the linguistic self-assessment showed a higher satisfaction in patients with maxillary defects .", "in patients with maxillary defects due to ablative tumor surgery , an increase in speech performance and intelligibility is possible by supplying resection prostheses ." ]
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
18,366,490
misoprostol is the drug of choice for medical abortion worldwide but consensus is yet to be reached regarding its preferred route of administration . to compare the outcome of sublingual with vaginal administrations of misoprostol for induction of second trimester abortion . a randomised comparative trial where @ women at @-@ weeks gestation , requiring medical abortion , were randomly assigned to sublingual or vaginal route for misoprostol administration with a dose schedule of @ microg three-hourly , up to a maximum five doses over @ h. the same doses were repeated for another @ h in non-responders . primary outcome measure was complete abortion rate at @ and @ h , and the secondary outcome measures were induction-abortion interval , failure rate , side-effects and patients ' preference to the route . no statistically significant differences in the complete abortion rates were observed at @ h ( @ % vs @ % , p = @ ) and at @ h ( @ % vs @ % , p = @ ) when sublingual and vaginal groups were compared . mean induction-abortion intervals in sublingual and vaginal groups were @ and @ h , respectively ( p = @ ) . other outcome measures were also more or less similar in both groups . differences in the incidence of side-effects were also statistically insignificant when both groups were compared . sublingual administration of the drug was preferred by most of the women as compared to vaginal administration ( p < @ ) . both sublingual and vaginal administrations of misoprostol are equally effective in inducing medical abortion during second trimester but sublingual route was preferred by the patients .
[ "misoprostol is the drug of choice for medical abortion worldwide but consensus is yet to be reached regarding its preferred route of administration .", "to compare the outcome of sublingual with vaginal administrations of misoprostol for induction of second trimester abortion .", "a randomised comparative trial where @ women at @-@ weeks gestation , requiring medical abortion , were randomly assigned to sublingual or vaginal route for misoprostol administration with a dose schedule of @ microg three-hourly , up to a maximum five doses over @ h.", "the same doses were repeated for another @ h in non-responders .", "primary outcome measure was complete abortion rate at @ and @ h , and the secondary outcome measures were induction-abortion interval , failure rate , side-effects and patients ' preference to the route .", "no statistically significant differences in the complete abortion rates were observed at @ h ( @ % vs @ % , p = @ ) and at @ h ( @ % vs @ % , p = @ ) when sublingual and vaginal groups were compared .", "mean induction-abortion intervals in sublingual and vaginal groups were @ and @ h , respectively ( p = @ ) .", "other outcome measures were also more or less similar in both groups .", "differences in the incidence of side-effects were also statistically insignificant when both groups were compared .", "sublingual administration of the drug was preferred by most of the women as compared to vaginal administration ( p < @ ) .", "both sublingual and vaginal administrations of misoprostol are equally effective in inducing medical abortion during second trimester but sublingual route was preferred by the patients ." ]
[ "OBJECTIVE", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
10,676,676
to test the hypothesis that a garlic supplement alters plasma lipoproteins , postprandial lipemia , low-density lipoprotein ( ldl ) size and high-density lipoprotein ( hdl ) subclass distribution differently in @ moderately hypercholesterolemic subjects classified as ldl subclass pattern a or b. garlic has been variably reported to reduce or not affect plasma cholesterol values . low-density lipoprotein pattern b is a common inherited disorder of lipoprotein metabolism that has been shown to have a significantly greater response to several lipid lowering treatments including low fat diet when compared with ldl pattern a individuals . a double blind , randomized , placebo controlled trial in an outpatient lipid research clinic was performed and included fifty moderately hypercholesterolemic subjects ( mean ldl cholesterol = @ + / - @ mg/dl ) classified as ldl subclass pattern a ( predominantly large ldl , n = @ ) or b ( predominantly small ldl , n = @ ) . following a two-month stabilization period , subjects were randomly assigned to a placebo or @ mg three times a day of a standardized garlic tablet for three months . for all subjects , ldl pattern a and b subjects combined , garlic treatment for three months resulted in no significant change in total cholesterol , ldl cholesterol , hdl cholesterol , hdl subclass distribution , postprandial triglycerides , apolipoprotein b , lipoprotein ( a ) ( lp [ a ] ) , ldl peak particle diameter or ldl subclass distribution . there was no significant difference in response for the same parameters among subjects classified as ldl pattern a or b with the exception of significantly greater ( p = @ ) reduction in mean peak particle diameter in pattern a subjects treated with either garlic or placebo . there was no significant change in ldl subclass distribution . this investigation confirms that garlic therapy has no effect on major plasma lipoproteins and further , that it has no impact on hdl subclasses , lp ( a ) , apolipoprotein b , postprandial triglycerides or ldl subclass distribution . garlic may have a greater effect on ldl particle diameter in ldl pattern a compared with pattern b subjects . this difference was not reflected in other plasma lipid measurements .
[ "to test the hypothesis that a garlic supplement alters plasma lipoproteins , postprandial lipemia , low-density lipoprotein ( ldl ) size and high-density lipoprotein ( hdl ) subclass distribution differently in @ moderately hypercholesterolemic subjects classified as ldl subclass pattern a or b.", "garlic has been variably reported to reduce or not affect plasma cholesterol values .", "low-density lipoprotein pattern b is a common inherited disorder of lipoprotein metabolism that has been shown to have a significantly greater response to several lipid lowering treatments including low fat diet when compared with ldl pattern a individuals .", "a double blind , randomized , placebo controlled trial in an outpatient lipid research clinic was performed and included fifty moderately hypercholesterolemic subjects ( mean ldl cholesterol = @ + / - @ mg/dl ) classified as ldl subclass pattern a ( predominantly large ldl , n = @ ) or b ( predominantly small ldl , n = @ ) .", "following a two-month stabilization period , subjects were randomly assigned to a placebo or @ mg three times a day of a standardized garlic tablet for three months .", "for all subjects , ldl pattern a and b subjects combined , garlic treatment for three months resulted in no significant change in total cholesterol , ldl cholesterol , hdl cholesterol , hdl subclass distribution , postprandial triglycerides , apolipoprotein b , lipoprotein ( a ) ( lp [ a ] ) , ldl peak particle diameter or ldl subclass distribution .", "there was no significant difference in response for the same parameters among subjects classified as ldl pattern a or b with the exception of significantly greater ( p = @ ) reduction in mean peak particle diameter in pattern a subjects treated with either garlic or placebo .", "there was no significant change in ldl subclass distribution .", "this investigation confirms that garlic therapy has no effect on major plasma lipoproteins and further , that it has no impact on hdl subclasses , lp ( a ) , apolipoprotein b , postprandial triglycerides or ldl subclass distribution .", "garlic may have a greater effect on ldl particle diameter in ldl pattern a compared with pattern b subjects .", "this difference was not reflected in other plasma lipid measurements ." ]
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
16,427,930
ileoscopy is the criterion standard for mucosal lesions of terminal ileum but is performed in @ % of colonoscopy activity , and the need for training is undefined . to assess the learning curve and skill-keeping line of ileoscopy . prospective randomized study . single gi endoscopy unit . adult outpatients referred for colonoscopy . patient randomization to ileocolonoscopy by trainees and seniors . ileoscopy skill was divided into the following : ileocecal valve ( icv ) intubation ( success rate , time ) and ileal exploration ( length , time ) . consecutive blocks of @ procedures were used to calculate the learning curve and the skill-keeping line . variables considered to influence icv intubation were the following : endoscopist experience , icv morphology , patient age , gender , body mass index , diverticular disease , and preceding abdominal/pelvic surgery . learning curve showed that competency in icv intubation ( @ % success rate ) and ileal exploration ( @ cm ) was achieved after @ procedures . the skill-keeping line showed that ileoscopy was easy ( @ % success rate ) , fast ( @ minute ) , and well accepted up to @ cm of the ileum . thin-lipped and volcanic icv are the most difficult and easiest to intubate , respectively . crohn 's disease and adenomas of the proximal edge of icv were diagnosed in @ % . training in ileoscopy is recommended to achieve competency , and endoscopists should consider practicing icv intubation to maintain and increase their skill . ileoscopy can be difficult when the icv is thin lipped or single bulged , and easy when it has a volcanic morphology .
[ "ileoscopy is the criterion standard for mucosal lesions of terminal ileum but is performed in @ % of colonoscopy activity , and the need for training is undefined .", "to assess the learning curve and skill-keeping line of ileoscopy .", "prospective randomized study .", "single gi endoscopy unit .", "adult outpatients referred for colonoscopy .", "patient randomization to ileocolonoscopy by trainees and seniors .", "ileoscopy skill was divided into the following : ileocecal valve ( icv ) intubation ( success rate , time ) and ileal exploration ( length , time ) .", "consecutive blocks of @ procedures were used to calculate the learning curve and the skill-keeping line .", "variables considered to influence icv intubation were the following : endoscopist experience , icv morphology , patient age , gender , body mass index , diverticular disease , and preceding abdominal/pelvic surgery .", "learning curve showed that competency in icv intubation ( @ % success rate ) and ileal exploration ( @ cm ) was achieved after @ procedures .", "the skill-keeping line showed that ileoscopy was easy ( @ % success rate ) , fast ( @ minute ) , and well accepted up to @ cm of the ileum .", "thin-lipped and volcanic icv are the most difficult and easiest to intubate , respectively .", "crohn 's disease and adenomas of the proximal edge of icv were diagnosed in @ % .", "training in ileoscopy is recommended to achieve competency , and endoscopists should consider practicing icv intubation to maintain and increase their skill .", "ileoscopy can be difficult when the icv is thin lipped or single bulged , and easy when it has a volcanic morphology ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
16,540,546
to estimate minimally important differences ( mids ) in scores for the modified rodnan skin score ( mrss ) and health assessment questionnaire-disability index ( haq-di ) in a clinical trial on diffuse systemic sclerosis ( ssc ) . @ people participated in a @-year , double-blind , randomised clinical trial comparing efficacy of low-dose and high-dose d-penicillamine in diffuse ssc . at @ , @ , @ and @ months , the investigator was asked to rate the change in the patient 's health since entering the study : markedly worsened , moderately worsened , slightly worsened , unchanged , slightly improved , moderately improved or markedly improved . patients who were rated as slightly improved were defined as the minimally changed subgroup and compared with patients rated as moderately or markedly improved . the mid estimates for the mrss improvement ranged from @ to @ ( @-@ @ effect size ) and for the haq-di from @ to @ ( @-@ @ effect size ) . patients who were rated to improve more than slightly were found to improve by @-@ @ ( @-@ @ effect size ) on the mrss and @-@ @ ( @-@ @ effect size ) on the haq-di score . mid estimates are provided for improvement in the mrss and haq-di scores , which can help in interpreting clinical trials on patients with ssc and be used for sample size calculation for future clinical trials on diffuse ssc .
[ "to estimate minimally important differences ( mids ) in scores for the modified rodnan skin score ( mrss ) and health assessment questionnaire-disability index ( haq-di ) in a clinical trial on diffuse systemic sclerosis ( ssc ) .", "@ people participated in a @-year , double-blind , randomised clinical trial comparing efficacy of low-dose and high-dose d-penicillamine in diffuse ssc .", "at @ , @ , @ and @ months , the investigator was asked to rate the change in the patient 's health since entering the study : markedly worsened , moderately worsened , slightly worsened , unchanged , slightly improved , moderately improved or markedly improved .", "patients who were rated as slightly improved were defined as the minimally changed subgroup and compared with patients rated as moderately or markedly improved .", "the mid estimates for the mrss improvement ranged from @ to @ ( @-@ @ effect size ) and for the haq-di from @ to @ ( @-@ @ effect size ) .", "patients who were rated to improve more than slightly were found to improve by @-@ @ ( @-@ @ effect size ) on the mrss and @-@ @ ( @-@ @ effect size ) on the haq-di score .", "mid estimates are provided for improvement in the mrss and haq-di scores , which can help in interpreting clinical trials on patients with ssc and be used for sample size calculation for future clinical trials on diffuse ssc ." ]
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
23,169,695
long-term pharmacological glucocorticoid ( gc ) therapy leads to skeletal muscle atrophy and weakness . the objective of this study was to investigate whether short-term treatment with gh and testosterone ( t ) can increase lean mass without major impairment of glucose homoeostasis in patients on gc therapy . this was a prospective , open-label , randomised , crossover study . twelve men ( age @ years ) on chronic gc treatment participated . the effects of @ weeks ' treatment with gh , testosterone and the combination of both on lean body mass ( lbm ) , appendicular skeletal muscle mass ( asmm ) , extracellular water ( ecw ) , body cell mass ( bcm ) and plasma glucose concentrations were investigated . lbm increased significantly after gh ( @ kg ; p = @ ) and gh + testosterone ( @ kg ; p = @ ) , but not testosterone alone . asmm increased after all three treatment periods ; by @ kg after gh ( p = @ ) , @ kg after gh + testosterone ( p = @ ) and @ kg after testosterone ( p = @ ) . the increase in asmm was larger with combined treatment than either gh or testosterone alone ( p < @ ) . ecw increased significantly after gh + testosterone by @ l ( p = @ ) but not after gh or testosterone alone . bcm increased slightly after single and combined treatments , but the changes were not significant . fasting glucose increased significantly after gh ( @ mmol/l , p = @ ) while both fasting ( @ mmol/l , p = @ ) and post glucose-load ( @ mmol/l , p = @ ) plasma glucose concentrations increased after gh + testosterone . gh and testosterone induce favourable and additive body compositional changes in men on chronic , low-dose gc treatment . in the doses used , combination therapy increases fasting and postprandial glucose concentration .
[ "long-term pharmacological glucocorticoid ( gc ) therapy leads to skeletal muscle atrophy and weakness .", "the objective of this study was to investigate whether short-term treatment with gh and testosterone ( t ) can increase lean mass without major impairment of glucose homoeostasis in patients on gc therapy .", "this was a prospective , open-label , randomised , crossover study .", "twelve men ( age @ years ) on chronic gc treatment participated .", "the effects of @ weeks ' treatment with gh , testosterone and the combination of both on lean body mass ( lbm ) , appendicular skeletal muscle mass ( asmm ) , extracellular water ( ecw ) , body cell mass ( bcm ) and plasma glucose concentrations were investigated .", "lbm increased significantly after gh ( @ kg ; p = @ ) and gh + testosterone ( @ kg ; p = @ ) , but not testosterone alone .", "asmm increased after all three treatment periods ; by @ kg after gh ( p = @ ) , @ kg after gh + testosterone ( p = @ ) and @ kg after testosterone ( p = @ ) .", "the increase in asmm was larger with combined treatment than either gh or testosterone alone ( p < @ ) .", "ecw increased significantly after gh + testosterone by @ l ( p = @ ) but not after gh or testosterone alone .", "bcm increased slightly after single and combined treatments , but the changes were not significant .", "fasting glucose increased significantly after gh ( @ mmol/l , p = @ ) while both fasting ( @ mmol/l , p = @ ) and post glucose-load ( @ mmol/l , p = @ ) plasma glucose concentrations increased after gh + testosterone .", "gh and testosterone induce favourable and additive body compositional changes in men on chronic , low-dose gc treatment .", "in the doses used , combination therapy increases fasting and postprandial glucose concentration ." ]
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
24,566,233
utilization rates ( urs ) for implantable cardioverter-defibrillators ( icds ) for primary prevention of sudden cardiac death ( ppscd ) are lacking in the community . the purpose of this study was to establish the icd ur in central indiana . a query run on @ hospitals in a health information exchange database in indianapolis identified patients between @ and @ with left ventricular ejection fraction ( ef ) @ . icd eligibility and utilization were determined from chart review . we identified @ patients with at least @ low ef study . two cohorts were analyzed : @ patients without and @ patients with international classification of diseases , ninth revision , clinical modification procedure code @ for icd placement . we manually reviewed a stratified ( by hospital ) random sample of @ patients from the no-icd procedure code cohort and found that @ ( @ % ) had no icd but had class i indications for icd . eight of @ ( @ % ) actually had icd implantation for ppscd . review of all @ patients in the icd procedure code cohort identified @ with icd implantation for ppscd . the icd ur ( ratio between patients with icd for ppscd and all with indication ) was @ % overall ( @ % confidence interval [ ci ] @ % -@ % ) . urs were @ % for males ( @ % ci @ % -@ % ) , @ % for females ( @ % ci @ % -@ % , p = @ vs males ) , @ % for whites ( @ % ci @ % -@ % ) , and @ % for blacks ( @ % ci @ % -@ % , p = @ vs whites ) . icd ur is @ % among patients meeting class i indications , suggesting further opportunities for improving guideline compliance . this study also illustrates limitations in calculating icd ur using large electronic repositories without hands-on chart review .
[ "utilization rates ( urs ) for implantable cardioverter-defibrillators ( icds ) for primary prevention of sudden cardiac death ( ppscd ) are lacking in the community .", "the purpose of this study was to establish the icd ur in central indiana .", "a query run on @ hospitals in a health information exchange database in indianapolis identified patients between @ and @ with left ventricular ejection fraction ( ef ) @ .", "icd eligibility and utilization were determined from chart review .", "we identified @ patients with at least @ low ef study .", "two cohorts were analyzed : @ patients without and @ patients with international classification of diseases , ninth revision , clinical modification procedure code @ for icd placement .", "we manually reviewed a stratified ( by hospital ) random sample of @ patients from the no-icd procedure code cohort and found that @ ( @ % ) had no icd but had class i indications for icd .", "eight of @ ( @ % ) actually had icd implantation for ppscd .", "review of all @ patients in the icd procedure code cohort identified @ with icd implantation for ppscd .", "the icd ur ( ratio between patients with icd for ppscd and all with indication ) was @ % overall ( @ % confidence interval [ ci ] @ % -@ % ) .", "urs were @ % for males ( @ % ci @ % -@ % ) , @ % for females ( @ % ci @ % -@ % , p = @ vs males ) , @ % for whites ( @ % ci @ % -@ % ) , and @ % for blacks ( @ % ci @ % -@ % , p = @ vs whites ) .", "icd ur is @ % among patients meeting class i indications , suggesting further opportunities for improving guideline compliance .", "this study also illustrates limitations in calculating icd ur using large electronic repositories without hands-on chart review ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
22,005,747
the study 's purpose was to analyze the effects of exercise training on exercise tolerance and left ventricular systolic function and structure in heart failure patients with preserved , mild , and moderate to severe reduction of left ventricular ejection fraction ( lvef ) . ninety-eight patients with moderate to severe ( n = @ ) , mild ( n = @ ) , and preserved ( n = @ ) lvef were randomly assigned to exercise training plus usual care ( n = @ ) or usual care alone ( n = @ ) in a randomization ratio of @:@ . left ventricular function , left ventricular dimensions , and exercise tolerance were assessed before and after each intervention . exercise tolerance and lvef increased with exercise training in all patient groups , whereas they remained unchanged after usual care alone . exercise training increased the mean ratio of early to late mitral inflow velocities ( e/a ratio ) and decreased deceleration time ( dt ) of early filling in patients with mild and preserved lvef . in patients with moderate to severe systolic dysfunction and advanced diastolic dysfunction ( dt < @ ms ) , exercise training decreased e/a ratio and increased dt , both of which were unchanged after usual care alone . in the remaining patients ( dt > @ ms ) , exercise training also improved mitral inflow patterns . exercise training decreased left ventricular dimensions in patients with mild and moderate to severe reduction of lvef but not in patients with preserved lvef . these results indicate that exercise training can improve the course of heart failure independent of the degree of baseline left ventricular dysfunction .
[ "the study 's purpose was to analyze the effects of exercise training on exercise tolerance and left ventricular systolic function and structure in heart failure patients with preserved , mild , and moderate to severe reduction of left ventricular ejection fraction ( lvef ) .", "ninety-eight patients with moderate to severe ( n = @ ) , mild ( n = @ ) , and preserved ( n = @ ) lvef were randomly assigned to exercise training plus usual care ( n = @ ) or usual care alone ( n = @ ) in a randomization ratio of @:@ .", "left ventricular function , left ventricular dimensions , and exercise tolerance were assessed before and after each intervention .", "exercise tolerance and lvef increased with exercise training in all patient groups , whereas they remained unchanged after usual care alone .", "exercise training increased the mean ratio of early to late mitral inflow velocities ( e/a ratio ) and decreased deceleration time ( dt ) of early filling in patients with mild and preserved lvef .", "in patients with moderate to severe systolic dysfunction and advanced diastolic dysfunction ( dt < @ ms ) , exercise training decreased e/a ratio and increased dt , both of which were unchanged after usual care alone .", "in the remaining patients ( dt > @ ms ) , exercise training also improved mitral inflow patterns .", "exercise training decreased left ventricular dimensions in patients with mild and moderate to severe reduction of lvef but not in patients with preserved lvef .", "these results indicate that exercise training can improve the course of heart failure independent of the degree of baseline left ventricular dysfunction ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
22,367,233
to investigate the feasibility of implementing a sleep education program ( sep ) for improving sleep in adult family home ( afh ) residents with dementia , and the relative efficacy of sep compared with usual care control in a pilot randomized controlled trial . thirty-seven afh staff-caregivers and @ residents with comorbid dementia and sleep disturbances . sep consisted of four training sessions with staff-caregivers to develop and implement individualized resident behavioral sleep plans . treatment fidelity to the sep was assessed following the national institutes of health ( nih ) behavior change consortium model utilizing trainer observations and staff-caregiver reports . resident sleep was assessed by wrist actigraphy at baseline , @-month posttreatment , and @-month follow-up . caregiver reports of resident daytime sleepiness , depression , and disruptive behaviors were also collected . each key area of treatment fidelity ( sep delivery , receipt , enactment ) was identified , measured , and yielded significant outcomes . staff-caregivers learned how to identify sleep scheduling , daily activity , and environmental factors that could contribute to nocturnal disturbances and developed and implemented strategies for modifying these factors . sep decreased the frequency and disturbance level of target resident nocturnal behaviors and improved actigraphically measured sleep percent and total sleep time over the @-month follow-up period compared with the control condition . results suggest behavioral interventions to improve sleep are feasible to implement in adult family homes and merit further investigation as a promising intervention for use with afh residents with dementia .
[ "to investigate the feasibility of implementing a sleep education program ( sep ) for improving sleep in adult family home ( afh ) residents with dementia , and the relative efficacy of sep compared with usual care control in a pilot randomized controlled trial .", "thirty-seven afh staff-caregivers and @ residents with comorbid dementia and sleep disturbances .", "sep consisted of four training sessions with staff-caregivers to develop and implement individualized resident behavioral sleep plans .", "treatment fidelity to the sep was assessed following the national institutes of health ( nih ) behavior change consortium model utilizing trainer observations and staff-caregiver reports .", "resident sleep was assessed by wrist actigraphy at baseline , @-month posttreatment , and @-month follow-up .", "caregiver reports of resident daytime sleepiness , depression , and disruptive behaviors were also collected .", "each key area of treatment fidelity ( sep delivery , receipt , enactment ) was identified , measured , and yielded significant outcomes .", "staff-caregivers learned how to identify sleep scheduling , daily activity , and environmental factors that could contribute to nocturnal disturbances and developed and implemented strategies for modifying these factors .", "sep decreased the frequency and disturbance level of target resident nocturnal behaviors and improved actigraphically measured sleep percent and total sleep time over the @-month follow-up period compared with the control condition .", "results suggest behavioral interventions to improve sleep are feasible to implement in adult family homes and merit further investigation as a promising intervention for use with afh residents with dementia ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
16,632,233
to compare the effects of prandial insulin therapy focusing on postprandial glucose control vs. basal insulin therapy focusing on fasting glucose control in patients with type @ diabetes . this was an open-label , randomized , parallel , three-arm multicenter trial in patients with type @ diabetes starting insulin treatment . patients ( n = @ ) were randomly assigned to @-week treatment with @x daily insulin lispro , @x daily lispro mid mixture ( midmix ; @ % lispro , @ % protaminated lispro ) , or @x daily insulin glargine ; oral antihyperglycemic agents were discontinued . primary end point was the postprandial glucose excursion @ h after breakfast at the end of study . secondary outcomes included hba@c , self-monitored blood glucose profiles , hypoglycemic episodes , body weight , and patient satisfaction . at the end of study , glucose excursions @ h after breakfast were significantly lower with lispro and midmix than with glargine ( p < @ for each vs. glargine ) : lispro , -@ + / -@ mmol/l ; midmix , +@ + / -@ mmol/l ; glargine , +@ + / -@ mmol/l . fasting glucose decreases were significantly greater with glargine ( -@ + / -@ mmol/l ) than with lispro or midmix ( -@ + / -@ mmol/l ; +@ + / -@ mmol/l ) . nevertheless , hba@c decreased by @ % ( lispro ) and @ % ( midmix ) , vs. @ % with glargine . hypoglycemic episodes were rare with @-@ @ self-reported episodes per @ patient-days . in patients with type @ diabetes starting insulin , @x daily prandial treatment with a rapid-acting analog focusing on postprandial glucose values enabled better control of postprandial and circadian blood glucose profiles than once-daily glargine , in spite suboptimal fasting glucose levels , which targets fasting glucose values . these results support studies suggesting that control of postprandial hyperglycemia plays a key role in achieving hba@c targets .
[ "to compare the effects of prandial insulin therapy focusing on postprandial glucose control vs. basal insulin therapy focusing on fasting glucose control in patients with type @ diabetes .", "this was an open-label , randomized , parallel , three-arm multicenter trial in patients with type @ diabetes starting insulin treatment .", "patients ( n = @ ) were randomly assigned to @-week treatment with @x daily insulin lispro , @x daily lispro mid mixture ( midmix ; @ % lispro , @ % protaminated lispro ) , or @x daily insulin glargine ; oral antihyperglycemic agents were discontinued .", "primary end point was the postprandial glucose excursion @ h after breakfast at the end of study .", "secondary outcomes included hba@c , self-monitored blood glucose profiles , hypoglycemic episodes , body weight , and patient satisfaction .", "at the end of study , glucose excursions @ h after breakfast were significantly lower with lispro and midmix than with glargine ( p < @ for each vs. glargine ) : lispro , -@ + / -@ mmol/l ; midmix , +@ + / -@ mmol/l ; glargine , +@ + / -@ mmol/l .", "fasting glucose decreases were significantly greater with glargine ( -@ + / -@ mmol/l ) than with lispro or midmix ( -@ + / -@ mmol/l ; +@ + / -@ mmol/l ) .", "nevertheless , hba@c decreased by @ % ( lispro ) and @ % ( midmix ) , vs. @ % with glargine .", "hypoglycemic episodes were rare with @-@ @ self-reported episodes per @ patient-days .", "in patients with type @ diabetes starting insulin , @x daily prandial treatment with a rapid-acting analog focusing on postprandial glucose values enabled better control of postprandial and circadian blood glucose profiles than once-daily glargine , in spite suboptimal fasting glucose levels , which targets fasting glucose values .", "these results support studies suggesting that control of postprandial hyperglycemia plays a key role in achieving hba@c targets ." ]
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
22,891,807
female sex workers who inject drugs ( fsw-idus ) are at risk of acquiring hiv , sexually transmitted infections ( sti ) and blood-borne infections through unprotected sex and sharing injection equipment . we conducted a @ factorial randomized controlled trial to evaluate combination interventions to simultaneously reduce sexual and injection risks among fsw-idus in tijuana and ciudad juarez , mexico . fsw-idus @ years reporting sharing injection equipment and unprotected sex with clients within the last month were randomized to one of four conditions based on an a priori randomization schedule , blinding interviewer/counselors to assignment . due to the extreme vulnerability of this population , we did not include a control group that would deny some women access to preventive information . all women received similar information regardless of group allocation ; the difference was in the way the information was delivered and the extent to which women had an interactive role . each condition was a single @-minute session , including either an interactive or didactic version of an injection risk intervention and sexual risk intervention . women underwent interviewer-administered surveys and testing for hiv , syphilis , gonorrhea , chlamydia , and trichomonas at baseline and quarterly for @ months . combined hiv/sti incidence will be the primary outcome . secondary outcomes are proportionate reductions in sharing of injection equipment and unprotected sex with clients . of @,@ women , @ ( @ % ) were excluded ( @ % were ineligible ; @ % refused to participate or did not return ) ; @ eligible women enrolled ( @ in tijuana ; @ in ciudad juarez ) . all @ participants completed the baseline interview , provided biological samples and were randomized to one of the four groups . during follow-up , @ participants ( @ % ) were lost to follow-up , of whom @ ( @ % ) had died , leaving @ participants for analysis . this study appears to be the first intervention to attempt to simultaneously reduce injection and sexual risk behaviors among fsw-idus . the factorial design will permit analysis to determine whether the combination of the two interactive interventions and/or its respective components are effective in reducing injection and/or sexual risks , which will have direct , tangible policy implications for mexico and potentially other resource-poor countries . nct@ .
[ "female sex workers who inject drugs ( fsw-idus ) are at risk of acquiring hiv , sexually transmitted infections ( sti ) and blood-borne infections through unprotected sex and sharing injection equipment .", "we conducted a @ factorial randomized controlled trial to evaluate combination interventions to simultaneously reduce sexual and injection risks among fsw-idus in tijuana and ciudad juarez , mexico .", "fsw-idus @ years reporting sharing injection equipment and unprotected sex with clients within the last month were randomized to one of four conditions based on an a priori randomization schedule , blinding interviewer/counselors to assignment .", "due to the extreme vulnerability of this population , we did not include a control group that would deny some women access to preventive information .", "all women received similar information regardless of group allocation ; the difference was in the way the information was delivered and the extent to which women had an interactive role .", "each condition was a single @-minute session , including either an interactive or didactic version of an injection risk intervention and sexual risk intervention .", "women underwent interviewer-administered surveys and testing for hiv , syphilis , gonorrhea , chlamydia , and trichomonas at baseline and quarterly for @ months .", "combined hiv/sti incidence will be the primary outcome .", "secondary outcomes are proportionate reductions in sharing of injection equipment and unprotected sex with clients .", "of @,@ women , @ ( @ % ) were excluded ( @ % were ineligible ; @ % refused to participate or did not return ) ; @ eligible women enrolled ( @ in tijuana ; @ in ciudad juarez ) .", "all @ participants completed the baseline interview , provided biological samples and were randomized to one of the four groups .", "during follow-up , @ participants ( @ % ) were lost to follow-up , of whom @ ( @ % ) had died , leaving @ participants for analysis .", "this study appears to be the first intervention to attempt to simultaneously reduce injection and sexual risk behaviors among fsw-idus .", "the factorial design will permit analysis to determine whether the combination of the two interactive interventions and/or its respective components are effective in reducing injection and/or sexual risks , which will have direct , tangible policy implications for mexico and potentially other resource-poor countries .", "nct@ ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
16,728,906
to compare oral risperidone and intramuscular ( im ) haloperidol , both in combination with im lorazepam , in the management of acute agitation and psychosis in the medical emergency department . in this prospective , randomized , placebo-controlled , double-blind study of @ patients presenting to the emergency department with acute agitation and/or psychosis , three groups of @ patients received oral and im medications : @ ) @ mg oral risperidone and @ mg im lorazepam ; @ ) @ mg oral haloperidol and @ mg im lorazepam ; @ ) oral placebo and @ mg im lorazepam . each treatment group received both an injection and a tablet to reduce treatment group variability . patients were evaluated using the brief psychiatric rating scale ( bprs ) and the positive and negative syndrome scale ( panss ) before receiving medication and at @ and @ minutes after medication was administered . the intergroup mean percent reductions in rating scale scores were compared using anova , chi-square , and kruskal-wallis tests . there were no statistically significant differences among the groups at any point . the two groups receiving an antipsychotic plus lorazepam showed a trend towards increased symptom reduction compared with the group receiving lorazepam alone , although this trend was not statistically significant . lorazepam alone was as effective as lorazepam plus haloperidol or lorazepam plus risperidone in this small trial . while not statistically significant , a trend toward better outcomes with combined treatment warrants further study .
[ "to compare oral risperidone and intramuscular ( im ) haloperidol , both in combination with im lorazepam , in the management of acute agitation and psychosis in the medical emergency department .", "in this prospective , randomized , placebo-controlled , double-blind study of @ patients presenting to the emergency department with acute agitation and/or psychosis , three groups of @ patients received oral and im medications : @ ) @ mg oral risperidone and @ mg im lorazepam ; @ ) @ mg oral haloperidol and @ mg im lorazepam ; @ ) oral placebo and @ mg im lorazepam .", "each treatment group received both an injection and a tablet to reduce treatment group variability .", "patients were evaluated using the brief psychiatric rating scale ( bprs ) and the positive and negative syndrome scale ( panss ) before receiving medication and at @ and @ minutes after medication was administered .", "the intergroup mean percent reductions in rating scale scores were compared using anova , chi-square , and kruskal-wallis tests .", "there were no statistically significant differences among the groups at any point .", "the two groups receiving an antipsychotic plus lorazepam showed a trend towards increased symptom reduction compared with the group receiving lorazepam alone , although this trend was not statistically significant .", "lorazepam alone was as effective as lorazepam plus haloperidol or lorazepam plus risperidone in this small trial .", "while not statistically significant , a trend toward better outcomes with combined treatment warrants further study ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
19,442,372
to prospectively evaluate the efficacy of routine ultrasound-guided fine-needle aspiration cytology ( fnac ) of thyroid nodules in an endemic area and to analyze the factors influencing it . patients with thyroid nodules were randomly subjected to either conventional palpation-guided fine-needle aspiration cytology ( pfnac ) or ultrasound-guided fine-needle aspiration cytology ( usfnac ) . the results of cytology were compared with the final histopathologic diagnosis in @ patients who had undergone surgery . the performance of both methods was individually analyzed in solid nodules , cystic nodules , and solitary and multinodular goitres . overall , usfnac showed a significantly higher sensitivity ( @ % vs @ % , p < @ ) , positive predictive value ( @ % vs @ % , p < @ ) , and greater diagnostic accuracy ( @ % vs @ % , p = @ ) compared with pfnac . the sensitivity of usfnac was significantly higher compared with that of pfnac in cystic and complex nodules ( @ % vs @ % , p < @ ) but not in solid nodules ( @ % vs @ % , p > @ ) . usfnac was more sensitive and more accurate than pfnac for detection of malignancy in multinodular goitres ( @ % vs @ % , p < @ ; @ % vs @ % , p < @ , respectively ) . the superiority of `` routine '' usfnac over pfnac is mainly due to its better performance in cystic nodules and multinodular goitres . hence , routine usfnac can be recommended in areas where such lesions constitute the majority of thyroid nodules .
[ "to prospectively evaluate the efficacy of routine ultrasound-guided fine-needle aspiration cytology ( fnac ) of thyroid nodules in an endemic area and to analyze the factors influencing it .", "patients with thyroid nodules were randomly subjected to either conventional palpation-guided fine-needle aspiration cytology ( pfnac ) or ultrasound-guided fine-needle aspiration cytology ( usfnac ) .", "the results of cytology were compared with the final histopathologic diagnosis in @ patients who had undergone surgery .", "the performance of both methods was individually analyzed in solid nodules , cystic nodules , and solitary and multinodular goitres .", "overall , usfnac showed a significantly higher sensitivity ( @ % vs @ % , p < @ ) , positive predictive value ( @ % vs @ % , p < @ ) , and greater diagnostic accuracy ( @ % vs @ % , p = @ ) compared with pfnac .", "the sensitivity of usfnac was significantly higher compared with that of pfnac in cystic and complex nodules ( @ % vs @ % , p < @ ) but not in solid nodules ( @ % vs @ % , p > @ ) .", "usfnac was more sensitive and more accurate than pfnac for detection of malignancy in multinodular goitres ( @ % vs @ % , p < @ ; @ % vs @ % , p < @ , respectively ) .", "the superiority of `` routine '' usfnac over pfnac is mainly due to its better performance in cystic nodules and multinodular goitres .", "hence , routine usfnac can be recommended in areas where such lesions constitute the majority of thyroid nodules ." ]
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
21,908,036
dalcetrapib modulates cholesteryl ester transfer protein ( cetp ) activity to raise high-density lipoprotein cholesterol ( hdl-c ) . after the failure of torcetrapib it was unknown if hdl produced by interaction with cetp had pro-atherogenic or pro-inflammatory properties . dal-plaque is the first multicentre study using novel non-invasive multimodality imaging to assess structural and inflammatory indices of atherosclerosis as primary endpoints . in this phase @b , double-blind , multicentre trial , patients ( aged @-@ years ) with , or with high risk of , coronary heart disease were randomly assigned ( @:@ ) to dalcetrapib @ mg/day or placebo for @ months . randomisation was done with a computer-generated randomisation code and was stratified by centre . patients and investigators were masked to treatment . coprimary endpoints were mri-assessed indices ( total vessel area , wall area , wall thickness , and normalised wall index [ average carotid ] ) after @ months and ( @ ) f-fluorodeoxyglucose ( ( @ ) f-fdg ) pet/ct assessment of arterial inflammation within an index vessel ( right carotid , left carotid , or ascending thoracic aorta ) after @ months , with no-harm boundaries established before unblinding of the trial . analysis was by intention to treat . this trial is registered at clinicaltrials.gov , nct@ . @ patients were screened and @ randomly assigned to placebo ( @ patients ) or dalcetrapib ( @ patients ) . for the coprimary mri and pet/ct endpoints , cis were below the no-harm boundary or the adverse change was numerically lower in the dalcetrapib group than in the placebo group . mri-derived change in total vessel area was reduced in patients given dalcetrapib compared with those given placebo after @ months ; absolute change from baseline relative to placebo was -@ mm ( @ ) ( @ % ci -@ to -@ ; nominal p = @ ) . the pet/ct measure of index vessel most-diseased-segment target-to-background ratio ( tbr ) was not different between groups , but carotid artery analysis showed a @ % reduction in most-diseased-segment tbr in the dalcetrapib group compared with the placebo group ( -@ [ @ % ci -@ to -@ ] ; nominal p = @ ) . dalcetrapib did not increase office blood pressure and the frequency of adverse events was similar between groups . dalcetrapib showed no evidence of a pathological effect related to the arterial wall over @ months . moreover , this trial suggests possible beneficial vascular effects of dalcetrapib , including the reduction in total vessel enlargement over @ months , but long-term safety and clinical outcomes efficacy of dalcetrapib need to be analysed . f hoffmann-la roche ltd. .
[ "dalcetrapib modulates cholesteryl ester transfer protein ( cetp ) activity to raise high-density lipoprotein cholesterol ( hdl-c ) .", "after the failure of torcetrapib it was unknown if hdl produced by interaction with cetp had pro-atherogenic or pro-inflammatory properties .", "dal-plaque is the first multicentre study using novel non-invasive multimodality imaging to assess structural and inflammatory indices of atherosclerosis as primary endpoints .", "in this phase @b , double-blind , multicentre trial , patients ( aged @-@ years ) with , or with high risk of , coronary heart disease were randomly assigned ( @:@ ) to dalcetrapib @ mg/day or placebo for @ months .", "randomisation was done with a computer-generated randomisation code and was stratified by centre .", "patients and investigators were masked to treatment .", "coprimary endpoints were mri-assessed indices ( total vessel area , wall area , wall thickness , and normalised wall index [ average carotid ] ) after @ months and ( @ ) f-fluorodeoxyglucose ( ( @ ) f-fdg ) pet/ct assessment of arterial inflammation within an index vessel ( right carotid , left carotid , or ascending thoracic aorta ) after @ months , with no-harm boundaries established before unblinding of the trial .", "analysis was by intention to treat .", "this trial is registered at clinicaltrials.gov , nct@ .", "@ patients were screened and @ randomly assigned to placebo ( @ patients ) or dalcetrapib ( @ patients ) .", "for the coprimary mri and pet/ct endpoints , cis were below the no-harm boundary or the adverse change was numerically lower in the dalcetrapib group than in the placebo group .", "mri-derived change in total vessel area was reduced in patients given dalcetrapib compared with those given placebo after @ months ; absolute change from baseline relative to placebo was -@ mm ( @ ) ( @ % ci -@ to -@ ; nominal p = @ ) .", "the pet/ct measure of index vessel most-diseased-segment target-to-background ratio ( tbr ) was not different between groups , but carotid artery analysis showed a @ % reduction in most-diseased-segment tbr in the dalcetrapib group compared with the placebo group ( -@ [ @ % ci -@ to -@ ] ; nominal p = @ ) .", "dalcetrapib did not increase office blood pressure and the frequency of adverse events was similar between groups .", "dalcetrapib showed no evidence of a pathological effect related to the arterial wall over @ months .", "moreover , this trial suggests possible beneficial vascular effects of dalcetrapib , including the reduction in total vessel enlargement over @ months , but long-term safety and clinical outcomes efficacy of dalcetrapib need to be analysed .", "f hoffmann-la roche ltd. ." ]
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
24,629,703
although limitation of pronation/supination following both-bone forearm fractures in children is often attributed to an angular malunion , no clinical study has compared pronation/supination and angular malalignment of the same child by analysis of prospectively collected clinical data . the purpose of this trial is to explore whether limitation of pronation/supination can be predicted by the degree of angular malalignment in children who sustained a both-bone forearm fracture . in four dutch hospitals , children aged @ years with a both-bone forearm fracture were prospectively followed up consecutive children for @-@ months . at the final follow-up , pronation/supination and angular malunion on radiographs were determined . between january @ and august @ , a total of @ children were prospectively followed up , of which @ children were included for analysis in this study . the mean age of the children was @ ( @ ) years , of which @ % were male and @ % fractured their dominant arm . the mean time to final examination was @ ( @ ) days . children with a metaphyseal both-bone fracture of the distal forearm with an angular malalignment of @ had a @-@ % chance of developing a clinically relevant limitation ( i.e. , < @ of pronation and/or supination ) , while children with an angular malalignment of @ had a @ % chance . children with diaphyseal both-bone forearm fractures with @ of angular malalignment had a @ % chance of developing a clinically relevant limitation , which showed no significant increase with a further increase of angular malalignment . children who sustained a both-bone forearm fracture localised in the distal metaphysis have a higher chance of developing a clinically relevant limitation of forearm rotation in case of a more severe angular malalignment , while children with a diaphyseal both-bone forearm fracture had a moderate chance of limitation , irrespective of the severity of the angular malalignment .
[ "although limitation of pronation/supination following both-bone forearm fractures in children is often attributed to an angular malunion , no clinical study has compared pronation/supination and angular malalignment of the same child by analysis of prospectively collected clinical data .", "the purpose of this trial is to explore whether limitation of pronation/supination can be predicted by the degree of angular malalignment in children who sustained a both-bone forearm fracture .", "in four dutch hospitals , children aged @ years with a both-bone forearm fracture were prospectively followed up consecutive children for @-@ months .", "at the final follow-up , pronation/supination and angular malunion on radiographs were determined .", "between january @ and august @ , a total of @ children were prospectively followed up , of which @ children were included for analysis in this study .", "the mean age of the children was @ ( @ ) years , of which @ % were male and @ % fractured their dominant arm .", "the mean time to final examination was @ ( @ ) days .", "children with a metaphyseal both-bone fracture of the distal forearm with an angular malalignment of @ had a @-@ % chance of developing a clinically relevant limitation ( i.e. , < @ of pronation and/or supination ) , while children with an angular malalignment of @ had a @ % chance .", "children with diaphyseal both-bone forearm fractures with @ of angular malalignment had a @ % chance of developing a clinically relevant limitation , which showed no significant increase with a further increase of angular malalignment .", "children who sustained a both-bone forearm fracture localised in the distal metaphysis have a higher chance of developing a clinically relevant limitation of forearm rotation in case of a more severe angular malalignment , while children with a diaphyseal both-bone forearm fracture had a moderate chance of limitation , irrespective of the severity of the angular malalignment ." ]
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
19,960,205
laparoscopic nissen fundoplication ( lnf ) has become established as the procedure of choice in the surgical management of the majority of patients suffering from gastroesophageal reflux disease ( gerd ) . postoperative paraesophageal herniation has an incidence range up to @ % in the immediate postoperative period . a prospective randomized trial was scheduled to study the role of posterior gastropexy , in combination with lnf , in prevention of paraesophageal herniation and improvement of postoperative results in surgical treatment of gerd . eighty-two patients with gerd were randomized to lnf combined with ( group a , n = @ ) or without ( group b , n = @ ) posterior gastropexy . subjective evaluation using disease-specific and generic questionnaires and structured interviews , and objective evaluation by endoscopy , esophageal manometry , and @-h ph monitoring , were performed before operation , at @ and @ months after surgery , and then every year . crura approximation was performed by stitches if the diameter was less than @ cm , or with a patch to reinforce the conventional crural closure or by tension-free technique to close the hiatus . posterior gastropexy ( group a ) was performed with one stitch between the posterior wall of the wrap and the crura near the arcuate ligament . sixteen patients of group a and @ patients of group b with concomitant abdominal diseases had simultaneous procedures [ cholecystectomy @ , vagotomy @ , ventral hernia repair @ , gastric polypectomy @ , gastric fundus diverticulectomy @ , gastrointestinal stromal tumor ( gist ) wedge resection @ ] . in mean follow-up of @ + / - @ months ( range @-@ months ) , one patient of group b presented with paraesophageal herniation in the first postoperative month ( reoperation ) , while recurrent gastroesophageal reflux ( visick iii or iv ) , successfully treated by medication , was noted in three patients of group b and in one patient of group a. only mild dysphagia , during the first two postoperative months , was noted in nine patients of group a and eight patients of group b. six patients of each group with barrett 's esophagus had endoscopic improvement after the second postoperative month . visick score in groups a/b was i in @/@ ( p < @ ) , ii in @/@ ( p = @ ) , iii in @/@ ( not significant , ns ) , and iv in @/@ . generally , visick score was i or ii in @/@ in groups a/b ( @ % / @ % , ns ) and iii or iv in @/@ ( @ % / @ % , p < @ ) . lnf combined with posterior gastropexy may prevent postoperative paraesophageal or sliding herniation in surgical treatment of gerd , providing better early and long-term postoperative results . ( registered clinical trial number : nct@ . www.clinicaltrials.gov . )
[ "laparoscopic nissen fundoplication ( lnf ) has become established as the procedure of choice in the surgical management of the majority of patients suffering from gastroesophageal reflux disease ( gerd ) .", "postoperative paraesophageal herniation has an incidence range up to @ % in the immediate postoperative period .", "a prospective randomized trial was scheduled to study the role of posterior gastropexy , in combination with lnf , in prevention of paraesophageal herniation and improvement of postoperative results in surgical treatment of gerd .", "eighty-two patients with gerd were randomized to lnf combined with ( group a , n = @ ) or without ( group b , n = @ ) posterior gastropexy .", "subjective evaluation using disease-specific and generic questionnaires and structured interviews , and objective evaluation by endoscopy , esophageal manometry , and @-h ph monitoring , were performed before operation , at @ and @ months after surgery , and then every year .", "crura approximation was performed by stitches if the diameter was less than @ cm , or with a patch to reinforce the conventional crural closure or by tension-free technique to close the hiatus .", "posterior gastropexy ( group a ) was performed with one stitch between the posterior wall of the wrap and the crura near the arcuate ligament .", "sixteen patients of group a and @ patients of group b with concomitant abdominal diseases had simultaneous procedures [ cholecystectomy @ , vagotomy @ , ventral hernia repair @ , gastric polypectomy @ , gastric fundus diverticulectomy @ , gastrointestinal stromal tumor ( gist ) wedge resection @ ] .", "in mean follow-up of @ + / - @ months ( range @-@ months ) , one patient of group b presented with paraesophageal herniation in the first postoperative month ( reoperation ) , while recurrent gastroesophageal reflux ( visick iii or iv ) , successfully treated by medication , was noted in three patients of group b and in one patient of group a. only mild dysphagia , during the first two postoperative months , was noted in nine patients of group a and eight patients of group b. six patients of each group with barrett 's esophagus had endoscopic improvement after the second postoperative month .", "visick score in groups a/b was i in @/@ ( p < @ ) , ii in @/@ ( p = @ ) , iii in @/@ ( not significant , ns ) , and iv in @/@ .", "generally , visick score was i or ii in @/@ in groups a/b ( @ % / @ % , ns ) and iii or iv in @/@ ( @ % / @ % , p < @ ) .", "lnf combined with posterior gastropexy may prevent postoperative paraesophageal or sliding herniation in surgical treatment of gerd , providing better early and long-term postoperative results .", "( registered clinical trial number : nct@ .", "www.clinicaltrials.gov . )" ]
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
23,410,885
vitamin d deficiency is common in the general public and athletic populations and may impair skeletal muscle function . we therefore assessed the effects of vitamin d@ supplementation on serum @ [ oh ] d concentrations and physical performance . @ club-level athletes were block randomised ( using baseline @ [ oh ] d concentrations ) into one of three groups receiving either a placebo ( plb ) , @ @ or @ @ iu/week oral vitamin d@ for @ weeks . serum @ [ oh ] d and muscle function ( @-rm bench press and leg press and vertical jump height ) were measured presupplementation , @ and @ weeks postsupplementation . vitamin d deficiency was defined in accordance with the us institute of medicine guideline ( < @ nmol/l ) . @ % of the subject population were vitamin d deficient at baseline ( meansd value @ nmol/l ) . following @ and @ weeks supplementation with @ @ iu ( @ and @ nmol/l , respectively ) or @ @ iu vitamin d@ ( @ and @ nmol/l , respectively ) , serum vitamin d concentrations increased in all participants , with every individual achieving concentrations greater than @ nmol/l . in contrast , vitamin d concentration in the plb group decreased at @ and @ weeks ( @ and @ nmol/l , respectively ) . increasing serum @ [ oh ] d had no significant effect on any physical performance parameter ( p > @ ) . both @ @ and @ @ iu vitamin d@ supplementation over a @-week period elevates serum @ [ oh ] d concentrations above @ nmol/l , but neither dose given for @ weeks improved our chosen measures of physical performance .
[ "vitamin d deficiency is common in the general public and athletic populations and may impair skeletal muscle function .", "we therefore assessed the effects of vitamin d@ supplementation on serum @ [ oh ] d concentrations and physical performance .", "@ club-level athletes were block randomised ( using baseline @ [ oh ] d concentrations ) into one of three groups receiving either a placebo ( plb ) , @ @ or @ @ iu/week oral vitamin d@ for @ weeks .", "serum @ [ oh ] d and muscle function ( @-rm bench press and leg press and vertical jump height ) were measured presupplementation , @ and @ weeks postsupplementation .", "vitamin d deficiency was defined in accordance with the us institute of medicine guideline ( < @ nmol/l ) .", "@ % of the subject population were vitamin d deficient at baseline ( meansd value @ nmol/l ) .", "following @ and @ weeks supplementation with @ @ iu ( @ and @ nmol/l , respectively ) or @ @ iu vitamin d@ ( @ and @ nmol/l , respectively ) , serum vitamin d concentrations increased in all participants , with every individual achieving concentrations greater than @ nmol/l .", "in contrast , vitamin d concentration in the plb group decreased at @ and @ weeks ( @ and @ nmol/l , respectively ) .", "increasing serum @ [ oh ] d had no significant effect on any physical performance parameter ( p > @ ) .", "both @ @ and @ @ iu vitamin d@ supplementation over a @-week period elevates serum @ [ oh ] d concentrations above @ nmol/l , but neither dose given for @ weeks improved our chosen measures of physical performance ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
18,822,974
to probe into the clinical therapeutic effect of acupuncture on coronary heart disease complicated by type @ diabetes mellitus ( cdm ) and the mechanism . using multi-central , randomized , controlled and blind methods , @ cases of cdm were divided into an observation group and a control group , @ cases in each group . they were treated by routine therapy for diabetes mellitus , and in the observation group , acupuncture at quchi ( li @ ) , hegu ( li @ ) , xuehai ( sp @ ) , zusanli ( st @ ) , yinlingquan ( sp @ ) , fenglong ( st @ ) . diji ( sp @ ) , sanyinjiao ( sp @ ) , etc. were added with the needling method for regulating spleen-stomach ; while in the control group , acupuncture was given at weiwanxiashu ( ex-b @ ) , feishu ( bl @ ) , pishu ( bl @ ) , shenshu ( bl @ ) , yanglingquan ( gb @ ) , etc. . the treatment was given twice a day in the two groups . clinical therapeutic effects were assessed according to clinical symptoms and signs , frequency and lasting time of angina pectoris , quantity of taking glycerol trinitrate , blood sugar , blood lipids , urinary albumin excretion rate , urinary beta@-microglobulin , urinary monocyte chemotactic protein-@ ( mcp-@ ) , ecg , heart color doppler , etc. . the needling method for regulating spleen-stomach not only could improve the symptoms and signs of the patient , but also could improve the degree of st segment moving down and the function of left artrium relaxation , and had benign regulative effect on glycometabolism , lipids metabolism and urinary albumin level , with significant differences as compared with the control group ( p < @ or p < @ ) . the markedly effective rate for improvement of ecg was @ % in the observation group and @ % in the control group . the needling method for regulating spleen-stomach can improve the damage of heart and blood vessels induced by abnormal sugar and lipids , decrease the level of urinary protein , inhibit mcp-@ excessive expression , relieve myocardial load and raise cardiac output in the patient of coronary heart disease complicated by type @ diabetes mellitus .
[ "to probe into the clinical therapeutic effect of acupuncture on coronary heart disease complicated by type @ diabetes mellitus ( cdm ) and the mechanism .", "using multi-central , randomized , controlled and blind methods , @ cases of cdm were divided into an observation group and a control group , @ cases in each group .", "they were treated by routine therapy for diabetes mellitus , and in the observation group , acupuncture at quchi ( li @ ) , hegu ( li @ ) , xuehai ( sp @ ) , zusanli ( st @ ) , yinlingquan ( sp @ ) , fenglong ( st @ ) .", "diji ( sp @ ) , sanyinjiao ( sp @ ) , etc. were added with the needling method for regulating spleen-stomach ; while in the control group , acupuncture was given at weiwanxiashu ( ex-b @ ) , feishu ( bl @ ) , pishu ( bl @ ) , shenshu ( bl @ ) , yanglingquan ( gb @ ) , etc. .", "the treatment was given twice a day in the two groups .", "clinical therapeutic effects were assessed according to clinical symptoms and signs , frequency and lasting time of angina pectoris , quantity of taking glycerol trinitrate , blood sugar , blood lipids , urinary albumin excretion rate , urinary beta@-microglobulin , urinary monocyte chemotactic protein-@ ( mcp-@ ) , ecg , heart color doppler , etc. .", "the needling method for regulating spleen-stomach not only could improve the symptoms and signs of the patient , but also could improve the degree of st segment moving down and the function of left artrium relaxation , and had benign regulative effect on glycometabolism , lipids metabolism and urinary albumin level , with significant differences as compared with the control group ( p < @ or p < @ ) .", "the markedly effective rate for improvement of ecg was @ % in the observation group and @ % in the control group .", "the needling method for regulating spleen-stomach can improve the damage of heart and blood vessels induced by abnormal sugar and lipids , decrease the level of urinary protein , inhibit mcp-@ excessive expression , relieve myocardial load and raise cardiac output in the patient of coronary heart disease complicated by type @ diabetes mellitus ." ]
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
16,308,853
use of blue dye alone as a marker for sentinel lymph node ( sln ) biopsy is effective , but combining it with isotope marking can improve the success rate . use of the isotope adds extra cost and there are potential radiation hazards . the two techniques were compared in a randomized trial . women with early breast cancer ( less than @ cm ) and no palpable axillary nodes were recruited . women older than @ years with multicentric cancers or previous surgery to the breast or axilla were excluded . patients were randomized to either blue dye alone or combined mapping for sln biopsy . all women had a level i and ii axillary dissection after the sln biopsy . a total of @ patients were recruited , of whom five were excluded from analysis . blue dye alone was used in @ women and @ had combined mapping . baseline demographic data were similar in the two cohorts . the success rate of sln biopsy was higher with combined mapping than with blue dye alone ( @ versus @ per cent ; p = @ ) . the accuracy and false-negative rate were similar ( accuracy @ per cent for combined mapping versus @ per cent for blue dye ; false-negative rate @ versus @ per cent ) . combined mapping was superior to blue dye alone in identification of the sln , but accuracy and false-negative rates were similar .
[ "use of blue dye alone as a marker for sentinel lymph node ( sln ) biopsy is effective , but combining it with isotope marking can improve the success rate .", "use of the isotope adds extra cost and there are potential radiation hazards .", "the two techniques were compared in a randomized trial .", "women with early breast cancer ( less than @ cm ) and no palpable axillary nodes were recruited .", "women older than @ years with multicentric cancers or previous surgery to the breast or axilla were excluded .", "patients were randomized to either blue dye alone or combined mapping for sln biopsy .", "all women had a level i and ii axillary dissection after the sln biopsy .", "a total of @ patients were recruited , of whom five were excluded from analysis .", "blue dye alone was used in @ women and @ had combined mapping .", "baseline demographic data were similar in the two cohorts .", "the success rate of sln biopsy was higher with combined mapping than with blue dye alone ( @ versus @ per cent ; p = @ ) .", "the accuracy and false-negative rate were similar ( accuracy @ per cent for combined mapping versus @ per cent for blue dye ; false-negative rate @ versus @ per cent ) .", "combined mapping was superior to blue dye alone in identification of the sln , but accuracy and false-negative rates were similar ." ]
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS" ]
22,624,776
knowledge translation ( kt ) research in long-term care ( ltc ) is still in its early stages . this protocol describes the evaluation of a multifaceted , interdisciplinary kt intervention aimed at integrating evidence-based osteoporosis and fracture prevention strategies into ltc care processes . the vitamin d and osteoporosis study ( vidos ) is underway in @ ltc homes ( n = @ intervention , n = @ control ) across ontario , canada . the primary objectives of this study are to assess the feasibility of delivering the kt intervention , and clinically , to increase the percent of ltc residents prescribed @ iu of vitamin d daily . eligibility criteria are ltc homes that are serviced by our partner pharmacy provider and have more than one prescribing physician . the target audience within each ltc home is the professional advisory committee ( pac ) , an interdisciplinary team who meets quarterly . the key elements of the intervention are three interactive educational sessions led by an expert opinion leader , action planning using a quality improvement cycle , audit and feedback reports , nominated internal champions , and reminders/point-of-care tools . control homes do not receive any intervention , however both intervention and control homes received educational materials as part of the ontario osteoporosis strategy . primary outcomes are feasibility measures ( recruitment , retention , attendance at educational sessions , action plan items identified and initiated , internal champions identified , performance reports provided and reviewed ) , and vitamin d ( @ iu/daily ) prescribing at @ and @ months . secondary outcomes include the proportion of residents prescribed calcium supplements and osteoporosis medications , and falls and fractures . qualitative methods will examine the experience of the ltc team with the kt intervention . homes are centrally randomized to intervention and control groups in blocks of variable size using a computer generated allocation sequence . randomization is stratified by home size and profit/nonprofit status . prescribing data retrieval and analysis are performed by blinded personnel . our study will contribute to an improved understanding of the feasibility and acceptability of a multifaceted intervention aimed at translating knowledge to ltc practitioners . lessons learned from this study will be valuable in guiding future research and understanding the complexities of translating knowledge in ltc .
[ "knowledge translation ( kt ) research in long-term care ( ltc ) is still in its early stages .", "this protocol describes the evaluation of a multifaceted , interdisciplinary kt intervention aimed at integrating evidence-based osteoporosis and fracture prevention strategies into ltc care processes .", "the vitamin d and osteoporosis study ( vidos ) is underway in @ ltc homes ( n = @ intervention , n = @ control ) across ontario , canada .", "the primary objectives of this study are to assess the feasibility of delivering the kt intervention , and clinically , to increase the percent of ltc residents prescribed @ iu of vitamin d daily .", "eligibility criteria are ltc homes that are serviced by our partner pharmacy provider and have more than one prescribing physician .", "the target audience within each ltc home is the professional advisory committee ( pac ) , an interdisciplinary team who meets quarterly .", "the key elements of the intervention are three interactive educational sessions led by an expert opinion leader , action planning using a quality improvement cycle , audit and feedback reports , nominated internal champions , and reminders/point-of-care tools .", "control homes do not receive any intervention , however both intervention and control homes received educational materials as part of the ontario osteoporosis strategy .", "primary outcomes are feasibility measures ( recruitment , retention , attendance at educational sessions , action plan items identified and initiated , internal champions identified , performance reports provided and reviewed ) , and vitamin d ( @ iu/daily ) prescribing at @ and @ months .", "secondary outcomes include the proportion of residents prescribed calcium supplements and osteoporosis medications , and falls and fractures .", "qualitative methods will examine the experience of the ltc team with the kt intervention .", "homes are centrally randomized to intervention and control groups in blocks of variable size using a computer generated allocation sequence .", "randomization is stratified by home size and profit/nonprofit status .", "prescribing data retrieval and analysis are performed by blinded personnel .", "our study will contribute to an improved understanding of the feasibility and acceptability of a multifaceted intervention aimed at translating knowledge to ltc practitioners .", "lessons learned from this study will be valuable in guiding future research and understanding the complexities of translating knowledge in ltc ." ]
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
24,036,634
to describe the psychometric properties and identify the minimally important difference ( mid ) of the hepatitis c virus patient-reported outcomes ( hcv-pro ) instrument . chronic hcv infection and associated treatments negatively affect pros of function and well-being . in a phase @ trial , hcv-infected patients received direct-acting antivirals ( daas ) for @weeks with peg-interferon/ribavirin ( peg-ifn/rbv ) for @weeks , or placebo plus peg-ifn/rbv . the hcv-pro total score , sf-@ pcs and mcs scores , eq-@d-@l , and eq vas were measured at baseline , week @ , end of daa treatment ( eodt ) , end of peg-ifn/rbv treatment ( eot ) , and posttreatment week @ ( svr@ ) . convergent validity of the hcv-pro was assessed by pearson 's correlation coefficients . discriminant validity was assessed by analyzing mean hcv-pro total scores by eq-@d anxiety/depression and pain/discomfort domain scores ( none vs. some ) and presence/absence of depression or fatigue adverse events . mid was identified through effect size ( es ) and receiver-operating characteristic ( roc ) curve analyses ( hcv-pro response vs. sf-@ pcs/mcs and eq vas mid thresholds ) . in @ patients ( @ % female ; @ % white ; @ % @years ) , correlations ( @-@ @ ) between hcv-pro total scores , sf-@ pcs/mcs scores , and eq vas scores at all time points supported convergent validity . hcv-pro total scores were reduced to @-@ points in patients impaired by depression , pain , or fatigue symptoms . impact of peg-ifn/rbv regimen on hcv-pro es increased over time ( eodt -@ ; eot -@ ) . es and roc curve analyses indicated an mid of -@ points . the hcv-pro was valid and responsive in the population studied . an mid of -@ points represented a threshold of clinical significance for the hcv-pro .
[ "to describe the psychometric properties and identify the minimally important difference ( mid ) of the hepatitis c virus patient-reported outcomes ( hcv-pro ) instrument .", "chronic hcv infection and associated treatments negatively affect pros of function and well-being .", "in a phase @ trial , hcv-infected patients received direct-acting antivirals ( daas ) for @weeks with peg-interferon/ribavirin ( peg-ifn/rbv ) for @weeks , or placebo plus peg-ifn/rbv .", "the hcv-pro total score , sf-@ pcs and mcs scores , eq-@d-@l , and eq vas were measured at baseline , week @ , end of daa treatment ( eodt ) , end of peg-ifn/rbv treatment ( eot ) , and posttreatment week @ ( svr@ ) .", "convergent validity of the hcv-pro was assessed by pearson 's correlation coefficients .", "discriminant validity was assessed by analyzing mean hcv-pro total scores by eq-@d anxiety/depression and pain/discomfort domain scores ( none vs. some ) and presence/absence of depression or fatigue adverse events .", "mid was identified through effect size ( es ) and receiver-operating characteristic ( roc ) curve analyses ( hcv-pro response vs. sf-@ pcs/mcs and eq vas mid thresholds ) .", "in @ patients ( @ % female ; @ % white ; @ % @years ) , correlations ( @-@ @ ) between hcv-pro total scores , sf-@ pcs/mcs scores , and eq vas scores at all time points supported convergent validity .", "hcv-pro total scores were reduced to @-@ points in patients impaired by depression , pain , or fatigue symptoms .", "impact of peg-ifn/rbv regimen on hcv-pro es increased over time ( eodt -@ ; eot -@ ) .", "es and roc curve analyses indicated an mid of -@ points .", "the hcv-pro was valid and responsive in the population studied .", "an mid of -@ points represented a threshold of clinical significance for the hcv-pro ." ]
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
15,622,577
severe fecal incontinence remains a disabling condition for the patient and a major therapeutic challenge for the physician . a series of observational studies have indicated that placement of an artificial bowel sphincter is associated with marked improvement of continence and quality of life . we have performed a prospective , randomized , controlled trial to evaluate the effect of placement of an artificial bowel sphincter ( acticon neosphincter ) on continence and quality of life in a group of severely incontinent adults . fourteen adults ( male : female , @:@ ; age range , @-@ years ) were randomized to placement of the artificial bowel sphincter or to a program of supportive care and were followed for six months from operation or entry into the study . the principal outcome measure was the level of continence , measured with the cleveland continence score , which provides a scale from @ to @ , representing perfect control through to total incontinence . secondary outcome measures were perioperative and late complications in the artificial bowel sphincter group , and the changes in quality of life in both groups . in the control group , the cleveland continence score was not significantly altered , with an initial value of @ + / - @ and a final value of @ + / - @ at six months . the artificial bowel sphincter group showed a highly significant improvement , changing from @ + / - @ before placement to @ + / - @ at six months after placement . one patient in the artificial bowel sphincter group had failure of healing of the perineal wound and explantation of the device ( @ percent explantation rate ) . there were two other significant perioperative events of recurring fecal impaction initially after placement in one patient and additional suturing of the perineal wound in another . there were major improvements in the quality of life for all measures in the artificial bowel sphincter group . there was significant improvement in all eight subscales of the medical outcome study short form-@ measures . the american medical systems quality of life score was raised from @ + / - @ to @ + / - @ and the beck depression inventory showed reduction from a level of mild depression ( @ + / - @ ) to a normal value ( @ + / - @ ) . no significant changes in any of the quality of life measures occurred for the control group . through a prospective , randomized trial format , we have shown that placement of an artificial bowel sphincter is safe and effective when compared with supportive care alone . perioperative and late problems are likely to continue to occur and between @ percent and @ percent of patients may require permanent explantation . for the remainder , the device is easy and discrete to use , highly effective in achieving continence , and able to generate a major improvement in the quality of life .
[ "severe fecal incontinence remains a disabling condition for the patient and a major therapeutic challenge for the physician .", "a series of observational studies have indicated that placement of an artificial bowel sphincter is associated with marked improvement of continence and quality of life .", "we have performed a prospective , randomized , controlled trial to evaluate the effect of placement of an artificial bowel sphincter ( acticon neosphincter ) on continence and quality of life in a group of severely incontinent adults .", "fourteen adults ( male : female , @:@ ; age range , @-@ years ) were randomized to placement of the artificial bowel sphincter or to a program of supportive care and were followed for six months from operation or entry into the study .", "the principal outcome measure was the level of continence , measured with the cleveland continence score , which provides a scale from @ to @ , representing perfect control through to total incontinence .", "secondary outcome measures were perioperative and late complications in the artificial bowel sphincter group , and the changes in quality of life in both groups .", "in the control group , the cleveland continence score was not significantly altered , with an initial value of @ + / - @ and a final value of @ + / - @ at six months .", "the artificial bowel sphincter group showed a highly significant improvement , changing from @ + / - @ before placement to @ + / - @ at six months after placement .", "one patient in the artificial bowel sphincter group had failure of healing of the perineal wound and explantation of the device ( @ percent explantation rate ) .", "there were two other significant perioperative events of recurring fecal impaction initially after placement in one patient and additional suturing of the perineal wound in another .", "there were major improvements in the quality of life for all measures in the artificial bowel sphincter group .", "there was significant improvement in all eight subscales of the medical outcome study short form-@ measures .", "the american medical systems quality of life score was raised from @ + / - @ to @ + / - @ and the beck depression inventory showed reduction from a level of mild depression ( @ + / - @ ) to a normal value ( @ + / - @ ) .", "no significant changes in any of the quality of life measures occurred for the control group .", "through a prospective , randomized trial format , we have shown that placement of an artificial bowel sphincter is safe and effective when compared with supportive care alone .", "perioperative and late problems are likely to continue to occur and between @ percent and @ percent of patients may require permanent explantation .", "for the remainder , the device is easy and discrete to use , highly effective in achieving continence , and able to generate a major improvement in the quality of life ." ]
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS" ]
23,218,801
statins are known to reduce plasma c-reactive protein ( crp ) concentrations . our goal was to define the mechanisms by which crp was reduced by maximal dose atorvastatin . eight subjects with combined hyperlipidemia ( @ men and @ postmenopausal women ) were enrolled in a randomized , placebo-controlled double-blind , cross over study . subjects underwent a @-h primed-constant infusion with deuterated leucine after @ weeks of placebo and @mg/day of atorvastatin . crp was isolated from lipoprotein deficient plasma , ( density > @ g/ml ) by affinity chromatography . isotopic enrichment was determined by gas chromatography/mass spectrometry . kinetic parameters were determined using compartmental modeling . paired t test and wilcoxon signed ranks test were used to compare differences between placebo and atorvastatin . compared with placebo , atorvastatin decreased median crp pool size by @ % ( @ vs @ mg ; p = @ ) , associated with a median crp fractional catabolic rate increase of @ % ( @ vs @ pools/day ; p = @ ) , with no significant effect on median crp production rate ( @ vs @ mg/kg/day ; p = @ ) . our data indicate that maximal doses of atorvastatin lower plasma crp levels by substantially decreasing the median crp plasma residence time from @ days to @ days , with no significant effect on the median crp production rate .
[ "statins are known to reduce plasma c-reactive protein ( crp ) concentrations .", "our goal was to define the mechanisms by which crp was reduced by maximal dose atorvastatin .", "eight subjects with combined hyperlipidemia ( @ men and @ postmenopausal women ) were enrolled in a randomized , placebo-controlled double-blind , cross over study .", "subjects underwent a @-h primed-constant infusion with deuterated leucine after @ weeks of placebo and @mg/day of atorvastatin .", "crp was isolated from lipoprotein deficient plasma , ( density > @ g/ml ) by affinity chromatography .", "isotopic enrichment was determined by gas chromatography/mass spectrometry .", "kinetic parameters were determined using compartmental modeling .", "paired t test and wilcoxon signed ranks test were used to compare differences between placebo and atorvastatin .", "compared with placebo , atorvastatin decreased median crp pool size by @ % ( @ vs @ mg ; p = @ ) , associated with a median crp fractional catabolic rate increase of @ % ( @ vs @ pools/day ; p = @ ) , with no significant effect on median crp production rate ( @ vs @ mg/kg/day ; p = @ ) .", "our data indicate that maximal doses of atorvastatin lower plasma crp levels by substantially decreasing the median crp plasma residence time from @ days to @ days , with no significant effect on the median crp production rate ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
8,117,360
to compare the influence on blood pressure , glucose , and lipid levels of a diet rich in monounsaturated fatty acids with an isocaloric , high-carbohydrate diet in @ niddm subjects . a crossover design with diet interventions and wash-out periods of @ wk was applied . the patients were randomly assigned to a @-wk treatment with a high-carbohydrate diet containing @ % of energy as carbohydrate and @ % of energy as fat ( @ % of energy as monounsaturated fatty acids ) or an isocaloric diet with @ % of energy as carbohydrate and @ % of energy as fat ( @ % of energy as monounsaturated fatty acids ) . on the last day of the two diets , @-h ambulatory blood pressure was measured and day profiles of glucose , hormones , and lipids were performed to a test menu rich in carbohydrates . the diet rich in monounsaturated fat reduced daytime systolic ( @ + / - @ vs. @ + / - @ mmhg , p < @ ) and @-h systolic blood pressure ( @ + / - @ vs. @ + / - @ mmhg , p < @ ) as well as daytime diastolic ( @ + / - @ vs. @ + / - @ mmhg , p < @ ) and diurnal diastolic blood pressure ( @ + / - @ vs. @ + / - @ mmhg , p < @ ) as compared with the high-carbohydrate diet . evidence of lowered blood glucose levels on the high-monounsaturated diet compared with the high-carbohydrate diet were found with lower fasting blood glucose ( @ + / - @ vs. @ + / - @ mm , p < @ ) , lower average blood glucose levels ( @ + / - @ vs. @ + / - @ mm , p < @ ) , and peak blood glucose responses ( @ + / - @ vs. @ + / - @ mm , p < @ ) . the two diets had the same impact on lipid levels . a diet rich in monounsaturated fat has beneficial effects on blood pressure and glucose metabolism , whereas no adverse effects on lipid composition in niddm subjects is detected .
[ "to compare the influence on blood pressure , glucose , and lipid levels of a diet rich in monounsaturated fatty acids with an isocaloric , high-carbohydrate diet in @ niddm subjects .", "a crossover design with diet interventions and wash-out periods of @ wk was applied .", "the patients were randomly assigned to a @-wk treatment with a high-carbohydrate diet containing @ % of energy as carbohydrate and @ % of energy as fat ( @ % of energy as monounsaturated fatty acids ) or an isocaloric diet with @ % of energy as carbohydrate and @ % of energy as fat ( @ % of energy as monounsaturated fatty acids ) .", "on the last day of the two diets , @-h ambulatory blood pressure was measured and day profiles of glucose , hormones , and lipids were performed to a test menu rich in carbohydrates .", "the diet rich in monounsaturated fat reduced daytime systolic ( @ + / - @ vs. @ + / - @ mmhg , p < @ ) and @-h systolic blood pressure ( @ + / - @ vs. @ + / - @ mmhg , p < @ ) as well as daytime diastolic ( @ + / - @ vs. @ + / - @ mmhg , p < @ ) and diurnal diastolic blood pressure ( @ + / - @ vs. @ + / - @ mmhg , p < @ ) as compared with the high-carbohydrate diet .", "evidence of lowered blood glucose levels on the high-monounsaturated diet compared with the high-carbohydrate diet were found with lower fasting blood glucose ( @ + / - @ vs. @ + / - @ mm , p < @ ) , lower average blood glucose levels ( @ + / - @ vs. @ + / - @ mm , p < @ ) , and peak blood glucose responses ( @ + / - @ vs. @ + / - @ mm , p < @ ) .", "the two diets had the same impact on lipid levels .", "a diet rich in monounsaturated fat has beneficial effects on blood pressure and glucose metabolism , whereas no adverse effects on lipid composition in niddm subjects is detected ." ]
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
22,193,396
the injection of stem cells in the context of acute myocardial infarction ( ami ) has been tested almost exclusively by anterograde intra-arterial coronary ( iac ) delivery . the retrograde intravenous coronary ( ivc ) delivery may be an additional route . to compare the cell distribution and retention pattern in the anterograde and retrograde routes . to investigate the role of microvascular obstruction by magnetic resonance imaging in cell retention by cardiac tissue after the injection of bone marrow mononuclear cells ( bmmc ) in ami . this was a prospective , open label , randomized study . patients with ami who presented : ( @ ) successful chemical or mechanical reperfusion within @ hours of symptom onset and ( @ ) infarction involving more than @ % of the left ventricle ( lv ) at the myocardial scintigraphy were included in the study . one hundred million bmmc were injected into the infarction-related artery through iac route , or vein through the ivc route . one percent of the injected cells were labeled with @mtc-hexamethyl-propylene-amine-oxime ( @mtc-hmpao ) . cell distribution was evaluated at @ and @ hours after the myocardial scintigraphy injection . cardiac magnetic resonance imaging was performed before cell injection . thirty patients were randomized into three groups . there were no serious adverse events related to the procedure . the early and late retention of labeled cells was higher in the iac group than in ivc group , regardless of the presence of microcirculation obstruction . the injection using the retrograde approach was feasible and safe . cell retention by cardiac tissue was higher using the anterograde approach . more studies are needed to confirm these findings .
[ "the injection of stem cells in the context of acute myocardial infarction ( ami ) has been tested almost exclusively by anterograde intra-arterial coronary ( iac ) delivery .", "the retrograde intravenous coronary ( ivc ) delivery may be an additional route .", "to compare the cell distribution and retention pattern in the anterograde and retrograde routes .", "to investigate the role of microvascular obstruction by magnetic resonance imaging in cell retention by cardiac tissue after the injection of bone marrow mononuclear cells ( bmmc ) in ami .", "this was a prospective , open label , randomized study .", "patients with ami who presented : ( @ ) successful chemical or mechanical reperfusion within @ hours of symptom onset and ( @ ) infarction involving more than @ % of the left ventricle ( lv ) at the myocardial scintigraphy were included in the study .", "one hundred million bmmc were injected into the infarction-related artery through iac route , or vein through the ivc route .", "one percent of the injected cells were labeled with @mtc-hexamethyl-propylene-amine-oxime ( @mtc-hmpao ) .", "cell distribution was evaluated at @ and @ hours after the myocardial scintigraphy injection .", "cardiac magnetic resonance imaging was performed before cell injection .", "thirty patients were randomized into three groups .", "there were no serious adverse events related to the procedure .", "the early and late retention of labeled cells was higher in the iac group than in ivc group , regardless of the presence of microcirculation obstruction .", "the injection using the retrograde approach was feasible and safe .", "cell retention by cardiac tissue was higher using the anterograde approach .", "more studies are needed to confirm these findings ." ]
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
22,249,909
maximal consumption of oxygen ( vo ( @ ) max ) during exercise is used in patients with chronic obstructive pulmonary disease ( copd ) to stratify perioperative risk . however , the impact of therapeutic hyperoxia ( i.e. , use of supplemental oxygen to prevent hypoxemia during exercise ) on ( vo ( @ ) max and other ventilatory parameters during maximal exercise in the resting normoxic copd population is poorly defined . a randomized , double-blind crossover study was performed in which resting normoxic subjects ( n = @ ) with copd underwent two standard symptom-limited , ramped-protocol bicycle ergometry cardiopulmonary exercise tests > @ days apart with fio ( @ ) of @ ( control ) and ~ @ ( therapeutic hyperoxia ) . vo ( @ ) max and other ventilatory parameters were compared using a paired two-sample t-test . therapeutic hyperoxia significantly increased vo ( @ ) max ( @ @ vs. @ @ ml/kg/min , p = @ ) , partial pressure of end-tidal carbon dioxide , and oxygen saturation and significantly decreased ve-vco ( @ ) slope , but it did not affect exercise time , maximum watts achieved , maximum minute ventilation , or change in end-expiratory lung volume . three of four subjects with vo ( @ ) max < @ ml/kg/min without supplemental oxygen increased vo ( @ ) max to @ ml/kg/min on therapeutic hyperoxia and potentially changed perioperative risk category . therapeutic hyperoxia in a resting normoxic copd population significantly improves vo ( @ ) max and may change perioperative risk stratification by conventional criteria . further studies are needed to determine if this change in stratification is appropriate .
[ "maximal consumption of oxygen ( vo ( @ ) max ) during exercise is used in patients with chronic obstructive pulmonary disease ( copd ) to stratify perioperative risk .", "however , the impact of therapeutic hyperoxia ( i.e. , use of supplemental oxygen to prevent hypoxemia during exercise ) on ( vo ( @ ) max and other ventilatory parameters during maximal exercise in the resting normoxic copd population is poorly defined .", "a randomized , double-blind crossover study was performed in which resting normoxic subjects ( n = @ ) with copd underwent two standard symptom-limited , ramped-protocol bicycle ergometry cardiopulmonary exercise tests > @ days apart with fio ( @ ) of @ ( control ) and ~ @ ( therapeutic hyperoxia ) .", "vo ( @ ) max and other ventilatory parameters were compared using a paired two-sample t-test .", "therapeutic hyperoxia significantly increased vo ( @ ) max ( @ @ vs. @ @ ml/kg/min , p = @ ) , partial pressure of end-tidal carbon dioxide , and oxygen saturation and significantly decreased ve-vco ( @ ) slope , but it did not affect exercise time , maximum watts achieved , maximum minute ventilation , or change in end-expiratory lung volume .", "three of four subjects with vo ( @ ) max < @ ml/kg/min without supplemental oxygen increased vo ( @ ) max to @ ml/kg/min on therapeutic hyperoxia and potentially changed perioperative risk category .", "therapeutic hyperoxia in a resting normoxic copd population significantly improves vo ( @ ) max and may change perioperative risk stratification by conventional criteria .", "further studies are needed to determine if this change in stratification is appropriate ." ]
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
1,384,949
survivors of advanced hodgkin disease , who were assigned randomly to treatment by mechlorethamine , vincristine , procarbazine , and prednisone ( mopp ) ; doxorubicin , bleomycin , vinblastine , and dacarbazine ( abvd ) ; or mopp alternating with abvd in a clinical trial of the cancer and leukemia group b ( protocol @ ) , were compared in terms of their psychosocial adaptation and psychosexual function an average of @ years after completion of treatment ( range , @-@ years ) . the study was undertaken to determine if there were differences among treatments in these functional areas as a consequence of differential long-term gonadal damage in the three regimens . ninety-three disease-free survivors of advanced hodgkin disease ( @ men and @ women ) were studied ( a minimum of @ year after completion of treatment ) by an interview conducted over the telephone . standardized measures were used to assess their psychologic , sexual , family , and vocational functioning , including the following tests : the psychosocial adjustment to illness scale -- self report , the brief symptom inventory , the profile of mood states , and the impact of event scale . contrary to expectation , no statistically significant differences in survivors ' psychosocial adaptation or psychosexual function were found by treatment arm . infertility ( based on survivors ' reports of medical test results and perceptions ) and lower income @ year before the diagnosis of cancer were significant predictors of poorer adjustment . most survivors reported a range of problems that they attributed to having had cancer : @ % , proven or perceived infertility ; @ % , sexual problems ; @ % , health and life insurance problems ; @ % , a negative socioeconomic effect ; and @ % , conditioned nausea , associated with visual or olfactory reminders of chemotherapy . no significant long-term advantage in psychosocial adaptation or psychosexual function was found for survivors of hodgkin disease treated by the less gonadally toxic abvd regimen @ to @ years after completion of treatment .
[ "survivors of advanced hodgkin disease , who were assigned randomly to treatment by mechlorethamine , vincristine , procarbazine , and prednisone ( mopp ) ; doxorubicin , bleomycin , vinblastine , and dacarbazine ( abvd ) ; or mopp alternating with abvd in a clinical trial of the cancer and leukemia group b ( protocol @ ) , were compared in terms of their psychosocial adaptation and psychosexual function an average of @ years after completion of treatment ( range , @-@ years ) .", "the study was undertaken to determine if there were differences among treatments in these functional areas as a consequence of differential long-term gonadal damage in the three regimens .", "ninety-three disease-free survivors of advanced hodgkin disease ( @ men and @ women ) were studied ( a minimum of @ year after completion of treatment ) by an interview conducted over the telephone .", "standardized measures were used to assess their psychologic , sexual , family , and vocational functioning , including the following tests : the psychosocial adjustment to illness scale -- self report , the brief symptom inventory , the profile of mood states , and the impact of event scale .", "contrary to expectation , no statistically significant differences in survivors ' psychosocial adaptation or psychosexual function were found by treatment arm .", "infertility ( based on survivors ' reports of medical test results and perceptions ) and lower income @ year before the diagnosis of cancer were significant predictors of poorer adjustment .", "most survivors reported a range of problems that they attributed to having had cancer : @ % , proven or perceived infertility ; @ % , sexual problems ; @ % , health and life insurance problems ; @ % , a negative socioeconomic effect ; and @ % , conditioned nausea , associated with visual or olfactory reminders of chemotherapy .", "no significant long-term advantage in psychosocial adaptation or psychosexual function was found for survivors of hodgkin disease treated by the less gonadally toxic abvd regimen @ to @ years after completion of treatment ." ]
[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
7,868,872
calcitonin gene-related peptide is a pleiotropic neuropeptide with potent vasodilatory properties , which interferes with renin release and might participate in cardiovascular homeostasis . we studied the influence of salt intake on the plasma concentration of calcitonin gene-related peptide , parathyroid hormone and on the renin-aldosterone system in @ patients with mild hypertension . each participant was studied after @ week of high salt intake ( @ mmol/day ) and after @ week of low salt intake ( @ mmol/day ) . the order of the two diet periods was randomized and crossover . plasma calcitonin gene-related peptide concentration was measured by radioimmunoassay after pre-extraction by reverse chromatography . seven patients were classified as salt-sensitive and eight as salt-resistant . in the whole group the low salt intake caused a significant decrease in arterial pressure and the expected increase in plasma renin activity and in plasma aldosterone concentration . such changes were accompanied by a significant increase in plasma calcitonin gene-related peptide . in salt-resistant patients in the sodium-replete state calcitonin gene-related peptide levels tended to be reduced in comparison with salt-sensitive patients . sodium depletion , however , caused a more pronounced rise in plasma calcitonin gene-related peptide in salt-resistant hypertensives , who attained levels close to those in salt-sensitive hypertensives . interestingly , in salt-resistant hypertensives changes in plasma calcitonin gene-related peptide were closely related to plasma renin activity ( r = @ , p = @ ) , whereas no such correlation was found in salt-sensitive patients . parathyroid hormone was not influenced by changes in salt intake . in subjects with mild hypertension calcitonin gene-related peptide is sensitive to changes in salt intake in the physiological range . such a response seems to be linked to the individual arterial pressure response to salt , because salt-resistant patients showed reduced calcitonin gene-related peptide levels in the sodium-replete state and a more pronounced calcitonin gene-related peptide increase , closely related to plasma renin activity , during sodium deprivation .
[ "calcitonin gene-related peptide is a pleiotropic neuropeptide with potent vasodilatory properties , which interferes with renin release and might participate in cardiovascular homeostasis .", "we studied the influence of salt intake on the plasma concentration of calcitonin gene-related peptide , parathyroid hormone and on the renin-aldosterone system in @ patients with mild hypertension .", "each participant was studied after @ week of high salt intake ( @ mmol/day ) and after @ week of low salt intake ( @ mmol/day ) .", "the order of the two diet periods was randomized and crossover .", "plasma calcitonin gene-related peptide concentration was measured by radioimmunoassay after pre-extraction by reverse chromatography .", "seven patients were classified as salt-sensitive and eight as salt-resistant .", "in the whole group the low salt intake caused a significant decrease in arterial pressure and the expected increase in plasma renin activity and in plasma aldosterone concentration .", "such changes were accompanied by a significant increase in plasma calcitonin gene-related peptide .", "in salt-resistant patients in the sodium-replete state calcitonin gene-related peptide levels tended to be reduced in comparison with salt-sensitive patients .", "sodium depletion , however , caused a more pronounced rise in plasma calcitonin gene-related peptide in salt-resistant hypertensives , who attained levels close to those in salt-sensitive hypertensives .", "interestingly , in salt-resistant hypertensives changes in plasma calcitonin gene-related peptide were closely related to plasma renin activity ( r = @ , p = @ ) , whereas no such correlation was found in salt-sensitive patients .", "parathyroid hormone was not influenced by changes in salt intake .", "in subjects with mild hypertension calcitonin gene-related peptide is sensitive to changes in salt intake in the physiological range .", "such a response seems to be linked to the individual arterial pressure response to salt , because salt-resistant patients showed reduced calcitonin gene-related peptide levels in the sodium-replete state and a more pronounced calcitonin gene-related peptide increase , closely related to plasma renin activity , during sodium deprivation ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
19,777,852
to make a study of the effect of chaihu shihuang soup on blood serum level tnf , il-@ and il-@ of severe acute pancratitis . sixty sap cases were divided at random into treatment group and control group ( @ cases each ) . the treatment group were given chai-hu-shi-huang-soup once a day ; the control group were given dachaihu soup once daily , with both treatment period for @ days . the tumor necrosis factor-alpha ( tnf-alpha ) , interleukin level @ ( il-@ ) and @ ( il-@ ) of both groups were determined before and after the treatment . we also had @ healthy cases . il-@ level in both groups was lower than healthy group while tnf-alpha and il-@ were higher than healthy group ( p < @ ) . after treatment , the treatment group 's tnf-alpha , il-@ level were comparatively lower than that in the control group ( p < @ ) , and il-@ level were clearly higher than that of the control group ( p < @ ) , comparison of the treatment group before treatment ( p < @ ) . chaihu shihuang soup can significantly regulate cytokine and improve early recovery of sap .
[ "to make a study of the effect of chaihu shihuang soup on blood serum level tnf , il-@ and il-@ of severe acute pancratitis .", "sixty sap cases were divided at random into treatment group and control group ( @ cases each ) .", "the treatment group were given chai-hu-shi-huang-soup once a day ; the control group were given dachaihu soup once daily , with both treatment period for @ days .", "the tumor necrosis factor-alpha ( tnf-alpha ) , interleukin level @ ( il-@ ) and @ ( il-@ ) of both groups were determined before and after the treatment .", "we also had @ healthy cases .", "il-@ level in both groups was lower than healthy group while tnf-alpha and il-@ were higher than healthy group ( p < @ ) .", "after treatment , the treatment group 's tnf-alpha , il-@ level were comparatively lower than that in the control group ( p < @ ) , and il-@ level were clearly higher than that of the control group ( p < @ ) , comparison of the treatment group before treatment ( p < @ ) .", "chaihu shihuang soup can significantly regulate cytokine and improve early recovery of sap ." ]
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
24,361,227
paclitaxel and gemcitabine ( pg ) combination chemotherapy is effective as a maintenance chemotherapeutic regimen in metastatic breast cancer ( mbc ) patients because it increases progression-free survival ( pfs ) , which increases overall survival ( os ) . the primary purpose of our study was to investigate the association between genetic polymorphisms in the genes involved in pg pathways and clinical outcomes in mbc patients treated with pg chemotherapy . a total of @ mbc patients were enrolled in this prospective multicenter trial of pg as the first-line chemotherapy . eighty-five of the @ patients from two institutes were available for analysis of single nucleotide polymorphisms ( snps ) . germline dna was extracted from peripheral blood mononuclear cells . thirty-eight snps in @ candidate genes selected from pathways that may influence the metabolism and transport of , or sensitivity , to pg were analysed . the median pfs and os of all @ patients were @ months ( @ % confidence interval [ ci ] : @-@ @ months ) and @ months ( @ % ci : @-@ @ months ) , respectively . an snp in slc@a@ ( rs@ , c/t ) was associated with os ( cc or ct versus tt : @ versus @ months , p = @ , hazard ratio [ hr ] @ , @ % ci : @-@ @ ) . slc@a@ ga haplotype had a significantly shorter os ( p = @ , hr @ , @ % ci : @-@ @ ) . rrm@ ( ribonucleotide reductase large subunit m@ ) snp ( rs@ ) , and haplotypes ataa and atga were significantly associated with neurotoxicity . genetic polymorphisms in slc@a@ , slc@a@ and rrm@ can influence the clinical outcome of mbc patients treated with pg chemotherapy . further studies on the functional mechanisms relating to these germline polymorphisms in these genes are warranted .
[ "paclitaxel and gemcitabine ( pg ) combination chemotherapy is effective as a maintenance chemotherapeutic regimen in metastatic breast cancer ( mbc ) patients because it increases progression-free survival ( pfs ) , which increases overall survival ( os ) .", "the primary purpose of our study was to investigate the association between genetic polymorphisms in the genes involved in pg pathways and clinical outcomes in mbc patients treated with pg chemotherapy .", "a total of @ mbc patients were enrolled in this prospective multicenter trial of pg as the first-line chemotherapy .", "eighty-five of the @ patients from two institutes were available for analysis of single nucleotide polymorphisms ( snps ) .", "germline dna was extracted from peripheral blood mononuclear cells .", "thirty-eight snps in @ candidate genes selected from pathways that may influence the metabolism and transport of , or sensitivity , to pg were analysed .", "the median pfs and os of all @ patients were @ months ( @ % confidence interval [ ci ] : @-@ @ months ) and @ months ( @ % ci : @-@ @ months ) , respectively .", "an snp in slc@a@ ( rs@ , c/t ) was associated with os ( cc or ct versus tt : @ versus @ months , p = @ , hazard ratio [ hr ] @ , @ % ci : @-@ @ ) .", "slc@a@ ga haplotype had a significantly shorter os ( p = @ , hr @ , @ % ci : @-@ @ ) .", "rrm@ ( ribonucleotide reductase large subunit m@ ) snp ( rs@ ) , and haplotypes ataa and atga were significantly associated with neurotoxicity .", "genetic polymorphisms in slc@a@ , slc@a@ and rrm@ can influence the clinical outcome of mbc patients treated with pg chemotherapy .", "further studies on the functional mechanisms relating to these germline polymorphisms in these genes are warranted ." ]
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
23,460,711
elderly patients form a heterogeneous population . evaluation of geriatric factors may help evaluate a patient 's health status to better adapt treatment . elderly patients with previously untreated metastatic colorectal cancer ( mcrc ) were randomly assigned to receive fluorouracil ( fu ) - based chemotherapy either alone or in combination with irinotecan ( iri ) in the fdration francophone de cancrologie digestive ( ffcd ) @-@ study . sites participating in the geriatric substudy completed geriatric screening tools to perform prognostic factor analyses for treatment safety during the first @ months after treatment initiation . the geriatric score was calculated in @ patients ( @ % ) . median age was @ years ( range , @ to @ years ) . the charlson comorbidity index was @ in @ % , mini-mental state examination ( mmse ) score was @/@ in @ % , and instrumental activities of daily living ( iadl ) showed impairment in @ % of the patients . seventy-one patients ( @ % ) had grade @ to @ toxicity , @ ( @ % ) had a dose-intensity reduction of more than @ % , and @ ( @ % ) had at least one unexpected hospitalization during the first @ months after starting treatment . in multivariate analysis , significant predictive factors for grade @-@ toxicity were iri arm ( odds ratio [ or ] , @ ) , mmse @/@ ( or , @ ) , and impaired iadl ( or , @ ) ; for dose-intensity reduction of > @ % , the significant predictive factors were alkaline phosphates > @ upper limit of normal ( or , @ ) and iri arm ( or , @ ) ; and for unexpected hospitalization , significant predictive factors were mmse @/@ ( or , @ ) and geriatric depression scale @ ( or , @ ) . geriatric factors ( mmse and iadl ) are predictive of severe toxicity or unexpected hospitalization ( mmse ) in a randomized prospective phase iii study in mcrc . these results suggest that cognitive function and autonomy impairment should be taken into account when choosing a regimen for chemotherapy .
[ "elderly patients form a heterogeneous population .", "evaluation of geriatric factors may help evaluate a patient 's health status to better adapt treatment .", "elderly patients with previously untreated metastatic colorectal cancer ( mcrc ) were randomly assigned to receive fluorouracil ( fu ) - based chemotherapy either alone or in combination with irinotecan ( iri ) in the fdration francophone de cancrologie digestive ( ffcd ) @-@ study .", "sites participating in the geriatric substudy completed geriatric screening tools to perform prognostic factor analyses for treatment safety during the first @ months after treatment initiation .", "the geriatric score was calculated in @ patients ( @ % ) .", "median age was @ years ( range , @ to @ years ) .", "the charlson comorbidity index was @ in @ % , mini-mental state examination ( mmse ) score was @/@ in @ % , and instrumental activities of daily living ( iadl ) showed impairment in @ % of the patients .", "seventy-one patients ( @ % ) had grade @ to @ toxicity , @ ( @ % ) had a dose-intensity reduction of more than @ % , and @ ( @ % ) had at least one unexpected hospitalization during the first @ months after starting treatment .", "in multivariate analysis , significant predictive factors for grade @-@ toxicity were iri arm ( odds ratio [ or ] , @ ) , mmse @/@ ( or , @ ) , and impaired iadl ( or , @ ) ; for dose-intensity reduction of > @ % , the significant predictive factors were alkaline phosphates > @ upper limit of normal ( or , @ ) and iri arm ( or , @ ) ; and for unexpected hospitalization , significant predictive factors were mmse @/@ ( or , @ ) and geriatric depression scale @ ( or , @ ) .", "geriatric factors ( mmse and iadl ) are predictive of severe toxicity or unexpected hospitalization ( mmse ) in a randomized prospective phase iii study in mcrc .", "these results suggest that cognitive function and autonomy impairment should be taken into account when choosing a regimen for chemotherapy ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
1,905,621
to study the effect of aldose reductase inhibition with ponalrestat on resistance to ischemic conduction block ( ricb ) in diabetic subjects . twenty-one healthy diabetic subjects without neuropathy were studied . subjects were randomized to take either a double-blind trial of @ mg ponalrestat or placebo once daily for @ wk . the median nerve action potential ( mnap ) and conduction velocity ( ncv ) , before and after @ min of forearm ischemia , were measured at the start and finish of the study . ricb ( mnap remaining after ischemia ) decreased from @ to @ % in the ponalrestat-treated group ( p less than @ ) and increased from @ + / - @ to @ + / - @ % in the placebo-treated group . mnap and ncv were unchanged in both groups . aldose reductase inhibition with ponalrestat partly reverses ricb in diabetes , perhaps by improving nerve hypoxia or reducing nerve energy substrates .
[ "to study the effect of aldose reductase inhibition with ponalrestat on resistance to ischemic conduction block ( ricb ) in diabetic subjects .", "twenty-one healthy diabetic subjects without neuropathy were studied .", "subjects were randomized to take either a double-blind trial of @ mg ponalrestat or placebo once daily for @ wk .", "the median nerve action potential ( mnap ) and conduction velocity ( ncv ) , before and after @ min of forearm ischemia , were measured at the start and finish of the study .", "ricb ( mnap remaining after ischemia ) decreased from @ to @ % in the ponalrestat-treated group ( p less than @ ) and increased from @ + / - @ to @ + / - @ % in the placebo-treated group .", "mnap and ncv were unchanged in both groups .", "aldose reductase inhibition with ponalrestat partly reverses ricb in diabetes , perhaps by improving nerve hypoxia or reducing nerve energy substrates ." ]
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
23,967,878
pain is a common symptom of chronic fatigue syndrome ( cfs ) . we investigated the effects of the treatments used in the pace trial [ cognitive behavioural therapy ( cbt ) , graded exercise therapy ( get ) , adaptive pacing therapy ( apt ) and specialist medical care ( smc ) ] on pain in cfs . we compared pain outcomes including individual painful symptoms , taken from the cdc criteria for cfs and co-morbid fibromyalgia . we modelled outcomes adjusting for baseline variables with multiple linear regression . significantly less frequent muscle pain was reported by patients following treatment with cbt compared to smc ( mean difference = @ unit change in frequency , p = @ ) , get versus smc ( @ , p = @ ) and get versus apt ( @ , p = @ ) . significantly less joint pain was reported following cbt versus apt ( @ , p = @ ) and get versus apt ( @ , p = @ ) . co-morbid fibromyalgia was less frequent following get versus smc ( @ , p = @ ) . the effect sizes of these differences varied between @ and @ for muscle pain and @ and @ for joint pain . treatment effects on pain were independent of ` change in fatigue ' . cbt and get were more effective in reducing the frequency of both muscle and joint pain than apt and smc . when compared to smc , get also reduced the frequency of co-morbid fibromyalgia ; the size of this effect on pain was small .
[ "pain is a common symptom of chronic fatigue syndrome ( cfs ) .", "we investigated the effects of the treatments used in the pace trial [ cognitive behavioural therapy ( cbt ) , graded exercise therapy ( get ) , adaptive pacing therapy ( apt ) and specialist medical care ( smc ) ] on pain in cfs .", "we compared pain outcomes including individual painful symptoms , taken from the cdc criteria for cfs and co-morbid fibromyalgia .", "we modelled outcomes adjusting for baseline variables with multiple linear regression .", "significantly less frequent muscle pain was reported by patients following treatment with cbt compared to smc ( mean difference = @ unit change in frequency , p = @ ) , get versus smc ( @ , p = @ ) and get versus apt ( @ , p = @ ) .", "significantly less joint pain was reported following cbt versus apt ( @ , p = @ ) and get versus apt ( @ , p = @ ) .", "co-morbid fibromyalgia was less frequent following get versus smc ( @ , p = @ ) .", "the effect sizes of these differences varied between @ and @ for muscle pain and @ and @ for joint pain .", "treatment effects on pain were independent of ` change in fatigue ' .", "cbt and get were more effective in reducing the frequency of both muscle and joint pain than apt and smc .", "when compared to smc , get also reduced the frequency of co-morbid fibromyalgia ; the size of this effect on pain was small ." ]
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
25,833,972
poor nutritional quality of complementary foods often limits growth . animal source foods , such as milk or meat , are often unaffordable . local affordable alternatives are needed . we evaluate the efficacy of @ newly developed , rice-based complementary food products : winfood ( wf ) with small fish and edible spiders and winfood-lite ( wf-l ) fortified with small fish , against @ existing fortified corn-soy blend products , csb + ( purely plant based ) and csb + + ( @ % dried skimmed milk ) . in total , @ infants aged @ mo were enrolled in this randomized , single-blinded study for @ mo , designed primarily to assess increments in fat-free mass by a deuterium dilution technique and change in plasma ferritin and soluble transferrin receptor . secondary endpoints were changes in anthropometric variables , including knee-heel length . data were analyzed by the intention-to-treat approach . there was no difference in fat-free mass increment in wf or wf-l compared with csb + [ wf : +@ kg ( @ % ci : -@ , @ kg ) ; wf-l : +@ kg ( @ % ci : -@ , @ kg ) ] or csb + + [ wf : -@ kg ( @ % ci : -@ , @ kg ) ; wf-l : +@ kg ( @ % ci : -@ , @ kg ) ] and no effect on iron status . the @-mm ( @ % ci : -@ , @ mm ) greater increase in knee-heel length in wf-l than in csb + was not significant . no difference was found between the locally produced products ( wf and wf-l ) and the csbs . micronutrient fortification may be necessary , and small fish may be an affordable alternative to milk to improve complementary foods . the dietary role of edible spiders needs to be further explored . this trial was registered at controlled-trials . com as isrctn@ .
[ "poor nutritional quality of complementary foods often limits growth .", "animal source foods , such as milk or meat , are often unaffordable .", "local affordable alternatives are needed .", "we evaluate the efficacy of @ newly developed , rice-based complementary food products : winfood ( wf ) with small fish and edible spiders and winfood-lite ( wf-l ) fortified with small fish , against @ existing fortified corn-soy blend products , csb + ( purely plant based ) and csb + + ( @ % dried skimmed milk ) .", "in total , @ infants aged @ mo were enrolled in this randomized , single-blinded study for @ mo , designed primarily to assess increments in fat-free mass by a deuterium dilution technique and change in plasma ferritin and soluble transferrin receptor .", "secondary endpoints were changes in anthropometric variables , including knee-heel length .", "data were analyzed by the intention-to-treat approach .", "there was no difference in fat-free mass increment in wf or wf-l compared with csb + [ wf : +@ kg ( @ % ci : -@ , @ kg ) ; wf-l : +@ kg ( @ % ci : -@ , @ kg ) ] or csb + + [ wf : -@ kg ( @ % ci : -@ , @ kg ) ; wf-l : +@ kg ( @ % ci : -@ , @ kg ) ] and no effect on iron status .", "the @-mm ( @ % ci : -@ , @ mm ) greater increase in knee-heel length in wf-l than in csb + was not significant .", "no difference was found between the locally produced products ( wf and wf-l ) and the csbs .", "micronutrient fortification may be necessary , and small fish may be an affordable alternative to milk to improve complementary foods .", "the dietary role of edible spiders needs to be further explored .", "this trial was registered at controlled-trials .", "com as isrctn@ ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
24,184,063
this study investigated the effect of contingent electrical stimulation ( ces ) on present pain intensity ( pi ) , pressure pain threshold ( ppt ) , and electromyographic events per hour of sleep ( emg/h ) on probable bruxers with masticatory myofascial pain . the study enrolled @ probable bruxers with masticatory myofascial pain in @ phases : ( @ ) baseline emg/h recording , ( @ ) biofeedback treatment using a ces paradigm ( active group , n = @ ) or inactive device ( control group , n = @ ) , and ( @ ) posttreatment emg/h recording . pi and ppt were assessed after each phase . analysis of variance models were used to compare results at a @ % significance level . patients in the active group had @ % lower emg/h in p@ and @ % lower emg/h in p@ , when compared with baseline . there were no differences in pi or ppt levels at any phase . ces could reduce emg activity associated with sleep bruxism in patients with masticatory myofascial pain but did not influence perceived pain .
[ "this study investigated the effect of contingent electrical stimulation ( ces ) on present pain intensity ( pi ) , pressure pain threshold ( ppt ) , and electromyographic events per hour of sleep ( emg/h ) on probable bruxers with masticatory myofascial pain .", "the study enrolled @ probable bruxers with masticatory myofascial pain in @ phases : ( @ ) baseline emg/h recording , ( @ ) biofeedback treatment using a ces paradigm ( active group , n = @ ) or inactive device ( control group , n = @ ) , and ( @ ) posttreatment emg/h recording .", "pi and ppt were assessed after each phase .", "analysis of variance models were used to compare results at a @ % significance level .", "patients in the active group had @ % lower emg/h in p@ and @ % lower emg/h in p@ , when compared with baseline .", "there were no differences in pi or ppt levels at any phase .", "ces could reduce emg activity associated with sleep bruxism in patients with masticatory myofascial pain but did not influence perceived pain ." ]
[ "BACKGROUND", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
21,742,094
mortality after st-elevation myocardial infarction ( stemi ) has reduced with reperfusion by primary percutaneous coronary intervention ( pci ) , which may have impacted on the adverse outcomes of cardiogenic shock ( cs ) and congestive heart failure ( chf ) . in the apex-ami trial , @,@ patients with stemi and planned primary pci were randomly assigned pexelizumab or matching placebo . post-randomization cs or chf was adjudicated by a clinical endpoints committee . treatment assignment to pexelizumab did not influence either endpoint or mortality rates . cardiogenic shock developed in @ patients ( @ % ) at a median of @ hours ( interquartile range @-@ @ ) post-randomization , and mortality at @ days was @ % . congestive heart failure occurred in @ of patients ( @ % ) at a median of @ days ( iqr @-@ @ ) , and mortality through @ days was @ % ; mortality among those with neither endpoint was @ % . patients with cs or chf were older , were more often female , and had more hypertension and diabetes , but smoked less compared with non-cs/chf patients ( all p < @ ) . independent mortality predictors among those with cs or chf were hyperlipidemia and a history of angina ( interaction p = @ and @ , respectively ) ; procedural predictors among survivors to pci were pre-pci thrombolysis in myocardial infarction ( timi ) flow @-@ and post-pci timi flow < @ ( p = @ and < @ , respectively ) . survival after cs remains poor despite aggressive reperfusion . both cs and chf remain the major causes of death among stemi patients undergoing primary pci . future studies should examine treatments that aim to reduce mortality in these highest risk patients .
[ "mortality after st-elevation myocardial infarction ( stemi ) has reduced with reperfusion by primary percutaneous coronary intervention ( pci ) , which may have impacted on the adverse outcomes of cardiogenic shock ( cs ) and congestive heart failure ( chf ) .", "in the apex-ami trial , @,@ patients with stemi and planned primary pci were randomly assigned pexelizumab or matching placebo .", "post-randomization cs or chf was adjudicated by a clinical endpoints committee .", "treatment assignment to pexelizumab did not influence either endpoint or mortality rates .", "cardiogenic shock developed in @ patients ( @ % ) at a median of @ hours ( interquartile range @-@ @ ) post-randomization , and mortality at @ days was @ % .", "congestive heart failure occurred in @ of patients ( @ % ) at a median of @ days ( iqr @-@ @ ) , and mortality through @ days was @ % ; mortality among those with neither endpoint was @ % .", "patients with cs or chf were older , were more often female , and had more hypertension and diabetes , but smoked less compared with non-cs/chf patients ( all p < @ ) .", "independent mortality predictors among those with cs or chf were hyperlipidemia and a history of angina ( interaction p = @ and @ , respectively ) ; procedural predictors among survivors to pci were pre-pci thrombolysis in myocardial infarction ( timi ) flow @-@ and post-pci timi flow < @ ( p = @ and < @ , respectively ) .", "survival after cs remains poor despite aggressive reperfusion .", "both cs and chf remain the major causes of death among stemi patients undergoing primary pci .", "future studies should examine treatments that aim to reduce mortality in these highest risk patients ." ]
[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
23,297,810
inappropriate use of antidepressants ( ad ) , defined as either continuation in the absence of a proper indication or continuation despite the lack of therapeutic efficacy , applies to approximately half of all long term ad users . we have designed a cluster randomized controlled clinical trial to assess the ( cost - ) effectiveness of an antidepressant cessation advice in the absence of a proper indication for maintenance treatment with antidepressants in primary care.we will select all patients using antidepressants for over @ months from @ general practices . patients will be diagnosed using the composite international diagnostic interview ( cidi ) version @ , extended with questions about the psychiatric history and previous treatment strategies . general practices will be randomized to either the intervention or the control group . in case of overtreatment , defined as the absence of a proper indication according to current guidelines , a cessation advice is given to the general practitioner . in the control groups no specific information is given . the primary outcome measure will be the proportion of patients that successfully discontinue their antidepressants at one-year follow-up . secondary outcomes are dimensional measures of psychopathology and costs . this study protocol provides a detailed overview of the design of the trial . study results will be of importance for refining current guidelines . if the intervention is effective it can be used in managed care programs . ntr@ .
[ "inappropriate use of antidepressants ( ad ) , defined as either continuation in the absence of a proper indication or continuation despite the lack of therapeutic efficacy , applies to approximately half of all long term ad users .", "we have designed a cluster randomized controlled clinical trial to assess the ( cost - ) effectiveness of an antidepressant cessation advice in the absence of a proper indication for maintenance treatment with antidepressants in primary care.we will select all patients using antidepressants for over @ months from @ general practices .", "patients will be diagnosed using the composite international diagnostic interview ( cidi ) version @ , extended with questions about the psychiatric history and previous treatment strategies .", "general practices will be randomized to either the intervention or the control group .", "in case of overtreatment , defined as the absence of a proper indication according to current guidelines , a cessation advice is given to the general practitioner .", "in the control groups no specific information is given .", "the primary outcome measure will be the proportion of patients that successfully discontinue their antidepressants at one-year follow-up .", "secondary outcomes are dimensional measures of psychopathology and costs .", "this study protocol provides a detailed overview of the design of the trial .", "study results will be of importance for refining current guidelines .", "if the intervention is effective it can be used in managed care programs .", "ntr@ ." ]
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
24,687,165
recent studies show that cerebral - amyloid ( a ) deposition is associated with blood pressure and measures of arterial stiffness in nondemented individuals . to examine the association between measures of arterial stiffness and change in a deposition over time . deposition of a was determined in a longitudinal observational study of aging by positron emission tomography using the pittsburgh compound b twice @ years apart in @ nondemented individuals @ years and older . arterial stiffness was measured with a noninvasive and automated waveform analyzer at the time closest to the second positron emission tomography scan . all measures were performed under standardized conditions . pulse wave velocity ( pwv ) was measured in the central ( carotid-femoral and heart-femoral pwv ) , peripheral ( femoral-ankle pwv ) , and mixed ( brachial-ankle pwv ) vascular beds . the change in a deposition over @ years was calculated from the @ individuals with repeat a-positron emission tomography . the proportion of a-positive individuals increased from @ % at baseline to @ % at follow-up . brachial-ankle pwv was significantly higher among a-positive participants at baseline and follow-up . femoral-ankle pwv was only higher among a-positive participants at follow-up . measures of central stiffness and blood pressure were not associated with a status at baseline or follow-up , but central stiffness was associated with a change in a deposition over time . each standard deviation increase in central stiffness ( carotid-femoral pwv , p = @ ; heart-femoral pwv , p = @ ) was linked with increases in a deposition over @ years . this study showed that a deposition increases with age in nondemented individuals and that arterial stiffness is strongly associated with the progressive deposition of a in the brain , especially in this age group . the association between a deposition changes over time and generalized arterial stiffness indicated a relationship between the severity of subclinical vascular disease and progressive cerebral a deposition .
[ "recent studies show that cerebral - amyloid ( a ) deposition is associated with blood pressure and measures of arterial stiffness in nondemented individuals .", "to examine the association between measures of arterial stiffness and change in a deposition over time .", "deposition of a was determined in a longitudinal observational study of aging by positron emission tomography using the pittsburgh compound b twice @ years apart in @ nondemented individuals @ years and older .", "arterial stiffness was measured with a noninvasive and automated waveform analyzer at the time closest to the second positron emission tomography scan .", "all measures were performed under standardized conditions .", "pulse wave velocity ( pwv ) was measured in the central ( carotid-femoral and heart-femoral pwv ) , peripheral ( femoral-ankle pwv ) , and mixed ( brachial-ankle pwv ) vascular beds .", "the change in a deposition over @ years was calculated from the @ individuals with repeat a-positron emission tomography .", "the proportion of a-positive individuals increased from @ % at baseline to @ % at follow-up .", "brachial-ankle pwv was significantly higher among a-positive participants at baseline and follow-up .", "femoral-ankle pwv was only higher among a-positive participants at follow-up .", "measures of central stiffness and blood pressure were not associated with a status at baseline or follow-up , but central stiffness was associated with a change in a deposition over time .", "each standard deviation increase in central stiffness ( carotid-femoral pwv , p = @ ; heart-femoral pwv , p = @ ) was linked with increases in a deposition over @ years .", "this study showed that a deposition increases with age in nondemented individuals and that arterial stiffness is strongly associated with the progressive deposition of a in the brain , especially in this age group .", "the association between a deposition changes over time and generalized arterial stiffness indicated a relationship between the severity of subclinical vascular disease and progressive cerebral a deposition ." ]
[ "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
19,078,934
in a low socioeconomic-status population of latina women , we evaluated the potential of storytelling ( st ) as a culturally aligned narrative method to promote colorectal cancer ( crc ) prevention and screening , compared to a risk tool ( rt ) - based intervention . seventy-eight women were randomized in this pilot study to one of two brief interventions to communicate crc risk reduction options : st or an rt. . measures of behavioral intentions relative to crc prevention and screening were obtained following the intervention . mean scores for intent to obtain and recommend endoscopy to others were significantly better for participants receiving st than rt ( p = @ and p = @ , respectively ) . all participants expressed intent to increase fruit and vegetable consumption and physical activity in response to interventions . post-intervention perceptions of cancer risk and fear of crc were not significantly different for participants receiving st compared with rt. . pre - to post-intervention perceptions of risk increased in st and decreased in rt , while decreases in fear were similar across both intervention groups . storytelling may be an effective approach for changing crc risk-related behavioral intentions among latinas . mediating factors ( such as perceived risk or fear ) often used to predict behavior change may not adequately explain the potential persuasive mechanisms of storytelling .
[ "in a low socioeconomic-status population of latina women , we evaluated the potential of storytelling ( st ) as a culturally aligned narrative method to promote colorectal cancer ( crc ) prevention and screening , compared to a risk tool ( rt ) - based intervention .", "seventy-eight women were randomized in this pilot study to one of two brief interventions to communicate crc risk reduction options : st or an rt. .", "measures of behavioral intentions relative to crc prevention and screening were obtained following the intervention .", "mean scores for intent to obtain and recommend endoscopy to others were significantly better for participants receiving st than rt ( p = @ and p = @ , respectively ) .", "all participants expressed intent to increase fruit and vegetable consumption and physical activity in response to interventions .", "post-intervention perceptions of cancer risk and fear of crc were not significantly different for participants receiving st compared with rt. .", "pre - to post-intervention perceptions of risk increased in st and decreased in rt , while decreases in fear were similar across both intervention groups .", "storytelling may be an effective approach for changing crc risk-related behavioral intentions among latinas .", "mediating factors ( such as perceived risk or fear ) often used to predict behavior change may not adequately explain the potential persuasive mechanisms of storytelling ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
17,520,382
to evaluate enhanced recovery after surgery ( eras ) protocol in colorectal surgery . from september @ to february @ , @ patients with colorectal cancer were randomly assigned to eras group and control group . the stress index , nutrition and metabolism index , intraoperative index and postoperative index were evaluated . six patients were excluded , @ in eras group ( @ cases received hepatectomy concomitantly and @ case received partial ileum resection ) , and @ in control group ( @ case received hepatectomy and @ case received colorectomy concomitantly , another presented asthma paroxysm ) . so there were @ cases in eras group and @ cases in control , with no statistical differences in sex , age , bmi index and operation types . deviation of homa-ir index of eras was lower than the control ( p > @ ) , the same as plasma cortisol at the @st day after operation ( p < @ ) , but plasma glucagons in the operation of eras group was higher than that of control ( p < @ ) . plasma glucose @st day after operation of eras group was lower than control ( p < @ ) , while plasma triglyceride intraoperation , at @st day , @nd day after operation of eras was higher than control ( p < @ ) . nitrogen negative balance of eras group was higher than control at @nd day after surgery , but is lower intraoperation and at @th day after operation ( p < @ ) . the time of exhaust gas and stool , time to eat fluidity and semi-fluidity , out-of-bed time and exercise time per-day , residual time and complication rate in eras group were better than those of control ( p < @ ) . post-operative expenses of eras was lower than that of control ( p < @ ) . eras can decrease surgical stress , increase functional recovery and reduce complication rate .
[ "to evaluate enhanced recovery after surgery ( eras ) protocol in colorectal surgery .", "from september @ to february @ , @ patients with colorectal cancer were randomly assigned to eras group and control group .", "the stress index , nutrition and metabolism index , intraoperative index and postoperative index were evaluated .", "six patients were excluded , @ in eras group ( @ cases received hepatectomy concomitantly and @ case received partial ileum resection ) , and @ in control group ( @ case received hepatectomy and @ case received colorectomy concomitantly , another presented asthma paroxysm ) .", "so there were @ cases in eras group and @ cases in control , with no statistical differences in sex , age , bmi index and operation types .", "deviation of homa-ir index of eras was lower than the control ( p > @ ) , the same as plasma cortisol at the @st day after operation ( p < @ ) , but plasma glucagons in the operation of eras group was higher than that of control ( p < @ ) .", "plasma glucose @st day after operation of eras group was lower than control ( p < @ ) , while plasma triglyceride intraoperation , at @st day , @nd day after operation of eras was higher than control ( p < @ ) .", "nitrogen negative balance of eras group was higher than control at @nd day after surgery , but is lower intraoperation and at @th day after operation ( p < @ ) .", "the time of exhaust gas and stool , time to eat fluidity and semi-fluidity , out-of-bed time and exercise time per-day , residual time and complication rate in eras group were better than those of control ( p < @ ) .", "post-operative expenses of eras was lower than that of control ( p < @ ) .", "eras can decrease surgical stress , increase functional recovery and reduce complication rate ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
11,390,121
to demonstrate equivalent efficacy for menopausal symptoms between aerodiol nasal spray and reference oral estradiol therapy , and to investigate the endometrial safety and tolerability of aerodiol in the long term . the efficacy of aerodiol @ microg , once daily , was compared with oral estradiol @ mg/day in a randomized , double-blind trial . a statistical test of noninferiority was performed on the mean absolute kupperman index ( ki ) obtained after @ and @ weeks of the two treatments . long-term safety was assessed in a @-year open-label study . the initial aerodiol dose was @ microg/day , and was adjusted if required . endometrial biopsies were obtained at inclusion and at the end of the trial and examined independently by two pathologists . in the equivalence trial , the ki improved similarly in the aerodiol group ( n = @ ) and the oral estradiol group ( n = @ ) . aerodiol was shown statistically to be at least as effective as oral therapy ( p < @ ) , but the incidences of mastalgia and withdrawal bleeding were significantly lower in the aerodiol group ( p < @ and p < @ , respectively ) . in the long-term safety trial ( n = @ ) , the rate of aerodiol treatment continuation at @ months was @ % , and there was no incidence of endometrial hyperplasia or cancer . aerodiol dose adaptation was performed by @ % of women . aerodiol was shown to have equivalent efficacy to reference oral estradiol therapy , but with better gynaecological acceptability . the endometrial safety of aerodiol was confirmed in the long term , and the ability to adjust the dosage easily was of benefit to a substantial proportion of women .
[ "to demonstrate equivalent efficacy for menopausal symptoms between aerodiol nasal spray and reference oral estradiol therapy , and to investigate the endometrial safety and tolerability of aerodiol in the long term .", "the efficacy of aerodiol @ microg , once daily , was compared with oral estradiol @ mg/day in a randomized , double-blind trial .", "a statistical test of noninferiority was performed on the mean absolute kupperman index ( ki ) obtained after @ and @ weeks of the two treatments .", "long-term safety was assessed in a @-year open-label study .", "the initial aerodiol dose was @ microg/day , and was adjusted if required .", "endometrial biopsies were obtained at inclusion and at the end of the trial and examined independently by two pathologists .", "in the equivalence trial , the ki improved similarly in the aerodiol group ( n = @ ) and the oral estradiol group ( n = @ ) .", "aerodiol was shown statistically to be at least as effective as oral therapy ( p < @ ) , but the incidences of mastalgia and withdrawal bleeding were significantly lower in the aerodiol group ( p < @ and p < @ , respectively ) .", "in the long-term safety trial ( n = @ ) , the rate of aerodiol treatment continuation at @ months was @ % , and there was no incidence of endometrial hyperplasia or cancer .", "aerodiol dose adaptation was performed by @ % of women .", "aerodiol was shown to have equivalent efficacy to reference oral estradiol therapy , but with better gynaecological acceptability .", "the endometrial safety of aerodiol was confirmed in the long term , and the ability to adjust the dosage easily was of benefit to a substantial proportion of women ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
20,369,533
to observe the operative technique and clinical effects of hidden tension suture after tibiofibular fracture fixation with absorbable thread . from october @ to october @ , @ patients ( @ sides ) with tibiofibular fracture underwent hidden tension suture ( test group , @ cases of @ sides ) and the common interrupted suture ( control group , @ cases of @ sides ) , including @ males and @ females with an median age of @ years ( @-@ years ) . fracture was caused by traffic accident in @ cases , by heavy bruise in @ cases , and by falling from height in @ cases . there were @ cases of single-side fracture , and @ cases of double-side fracture . of them , @ sides were closed fracture , and @ sides were open fracture ( including @ sides of type i , @ sides of type ii , and @ sides of type iiia according to gustilo classification for the open fracture ) . the locations were upper tibia in @ sides , middle tibia in @ sides , and lower tibia in @ sides . the x-ray films showed that there were transverse fractures in @ sides , oblique fractures in @ sides , spiral fractures in @ sides , and comminuted fractures in @ sides . no blood vessel injury , osteofascial compartment syndrome and pressure syndrome were observed . the time from injury to operation was @ hours to @ days with an average of @ days . of @ sides , @ sides were fixed by interlocking nails , others by internal steel plate . in control group , healing by first intention was achieved in @ cases ( @ % ) and healing by secondary intention in @ cases ( @ % ) ; in test group , healing by first intention was achieved in @ cases ( @ % ) and healing by secondary intention in @ cases ( @ % ) ; and showing significant difference ( p < @ ) . all patients were followed up for @ months to @ years ( average @ months ) . no complication occurred in test group , and scar was obvious in the control group . the hidden tension suture with absorbable thread can be a good alternative for the incision healing after tibiofibular fracture fixation . it deals with the problems of the incision tension and difficult-to-suture , and is good for the incision healing after operation .
[ "to observe the operative technique and clinical effects of hidden tension suture after tibiofibular fracture fixation with absorbable thread .", "from october @ to october @ , @ patients ( @ sides ) with tibiofibular fracture underwent hidden tension suture ( test group , @ cases of @ sides ) and the common interrupted suture ( control group , @ cases of @ sides ) , including @ males and @ females with an median age of @ years ( @-@ years ) .", "fracture was caused by traffic accident in @ cases , by heavy bruise in @ cases , and by falling from height in @ cases .", "there were @ cases of single-side fracture , and @ cases of double-side fracture .", "of them , @ sides were closed fracture , and @ sides were open fracture ( including @ sides of type i , @ sides of type ii , and @ sides of type iiia according to gustilo classification for the open fracture ) .", "the locations were upper tibia in @ sides , middle tibia in @ sides , and lower tibia in @ sides .", "the x-ray films showed that there were transverse fractures in @ sides , oblique fractures in @ sides , spiral fractures in @ sides , and comminuted fractures in @ sides .", "no blood vessel injury , osteofascial compartment syndrome and pressure syndrome were observed .", "the time from injury to operation was @ hours to @ days with an average of @ days .", "of @ sides , @ sides were fixed by interlocking nails , others by internal steel plate .", "in control group , healing by first intention was achieved in @ cases ( @ % ) and healing by secondary intention in @ cases ( @ % ) ; in test group , healing by first intention was achieved in @ cases ( @ % ) and healing by secondary intention in @ cases ( @ % ) ; and showing significant difference ( p < @ ) .", "all patients were followed up for @ months to @ years ( average @ months ) .", "no complication occurred in test group , and scar was obvious in the control group .", "the hidden tension suture with absorbable thread can be a good alternative for the incision healing after tibiofibular fracture fixation .", "it deals with the problems of the incision tension and difficult-to-suture , and is good for the incision healing after operation ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
21,641,516
to observe the effect of regular yogic practices and self-discipline in reducing body fat and elevated lipids in cad patients . in this study one hundred seventy ( @ ) subjects , of both sexes having coronary artery disease were randomly selected form department of cardiology . subjects were divided in to two groups randomly in yoga group and in non-yoga group , eighty five ( @ ) in each group . out of these ( @ subjects ) , one hundred fifty four ( @ ) completed the study protocol . time line : the yogic intervention consisted of @-@ min/day , five days in a week till six months in the department of physiology csmmu up lucknow . body fat testing and estimation of lipid profile were done of the both groups at zero time and after six months of yogic intervention in yoga group and without yogic intervention in non yoga group . in present study , bmi ( p < @ ) , fat % ( p < @ ) , fat free mass ( p < @ ) , sbp ( p < @ ) , dbp ( p < @ ) , heart rate ( p < @ ) , total cholesterol ( p < @ ) , triglycerides ( p < @ ) , hdl ( p < @ ) and low density lipoprotein ( p < @ ) were changed significantly . reduction of sbp , dbp , heart rate , body fat % , total cholesterol , triglycerides and ldl after regular yogic practices is beneficial for cardiac and hypertensive patients . therefore yogic practices included in this study are helpful for the patients of coronary artery disease .
[ "to observe the effect of regular yogic practices and self-discipline in reducing body fat and elevated lipids in cad patients .", "in this study one hundred seventy ( @ ) subjects , of both sexes having coronary artery disease were randomly selected form department of cardiology .", "subjects were divided in to two groups randomly in yoga group and in non-yoga group , eighty five ( @ ) in each group .", "out of these ( @ subjects ) , one hundred fifty four ( @ ) completed the study protocol .", "time line : the yogic intervention consisted of @-@ min/day , five days in a week till six months in the department of physiology csmmu up lucknow .", "body fat testing and estimation of lipid profile were done of the both groups at zero time and after six months of yogic intervention in yoga group and without yogic intervention in non yoga group .", "in present study , bmi ( p < @ ) , fat % ( p < @ ) , fat free mass ( p < @ ) , sbp ( p < @ ) , dbp ( p < @ ) , heart rate ( p < @ ) , total cholesterol ( p < @ ) , triglycerides ( p < @ ) , hdl ( p < @ ) and low density lipoprotein ( p < @ ) were changed significantly .", "reduction of sbp , dbp , heart rate , body fat % , total cholesterol , triglycerides and ldl after regular yogic practices is beneficial for cardiac and hypertensive patients .", "therefore yogic practices included in this study are helpful for the patients of coronary artery disease ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
20,131,031
to observe the effect of chinese medicine therapy for strengthening-pi and nourishing-shen ( spns ) in preventing lamivudine induced ymdd mutation and its immunological mechanism . one hundred and sixty chronic hepatitis b ( chb ) patients with positive hbeag were equally assigned to two groups at random : the observation group and the control group . patients in the observation group were treated with lamivudine combined with spns , and those in the control group were treated with lamivudine only , with the treatment lasting for @ weeks in total . changes in indexes , including liver function , hbeag , hbv-dna , ymdd variation , cd ( @ ) , cd ( @ ) / cd ( @ ) ratio , interferon-gamma ( ifn-gamma ) , interleukin-@ ( il-@ ) , blood routine , renal function , as well as any adverse reactions that occurred in patients , were observed at different time points . the alt , ast recovery rate and hbv-dna negatively inversing rate at the @th week , the @th week and the @nd week were all higher ( p < @ ) ; meanwhile , the ymdd mutation rate at the @th week and the @nd week was lower ( p < @ ) in the observation group than in the control group . the posttreatment levels of cd ( @ ) , cd ( @ ) / cd ( @ ) ratio , ifn-gamma , and il-@ as well as the pre-post treatment difference of these indexes in the observation group were significantly different from those in the control group ( p < @ ) . chinese medicine spns therapy can significantly reduce the ymdd variation of hbv , and the mechanism may be related to its regulation of the cd ( @ ) level , cd ( @ ) / cd ( @ ) ratio and th@/th@ balance .
[ "to observe the effect of chinese medicine therapy for strengthening-pi and nourishing-shen ( spns ) in preventing lamivudine induced ymdd mutation and its immunological mechanism .", "one hundred and sixty chronic hepatitis b ( chb ) patients with positive hbeag were equally assigned to two groups at random : the observation group and the control group .", "patients in the observation group were treated with lamivudine combined with spns , and those in the control group were treated with lamivudine only , with the treatment lasting for @ weeks in total .", "changes in indexes , including liver function , hbeag , hbv-dna , ymdd variation , cd ( @ ) , cd ( @ ) / cd ( @ ) ratio , interferon-gamma ( ifn-gamma ) , interleukin-@ ( il-@ ) , blood routine , renal function , as well as any adverse reactions that occurred in patients , were observed at different time points .", "the alt , ast recovery rate and hbv-dna negatively inversing rate at the @th week , the @th week and the @nd week were all higher ( p < @ ) ; meanwhile , the ymdd mutation rate at the @th week and the @nd week was lower ( p < @ ) in the observation group than in the control group .", "the posttreatment levels of cd ( @ ) , cd ( @ ) / cd ( @ ) ratio , ifn-gamma , and il-@ as well as the pre-post treatment difference of these indexes in the observation group were significantly different from those in the control group ( p < @ ) .", "chinese medicine spns therapy can significantly reduce the ymdd variation of hbv , and the mechanism may be related to its regulation of the cd ( @ ) level , cd ( @ ) / cd ( @ ) ratio and th@/th@ balance ." ]
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
7,694,528
inhaled anesthetics can alter the arrhythmogenicity of exogenously administered epinephrine . although swine anesthetized with desflurane or isoflurane do not differ in their arrhythmic response to exogenous epinephrine , the relative effect of epinephrine in the presence of these anesthetics in humans is untested . the authors compared the arrhythmogenicity of submucosally administered epinephrine in @ asa physical status @ and @ patients undergoing transsphenoidal resection of pituitary tumors who were randomly assigned to receive @-@ @ mac desflurane or isoflurane anesthesia . a surgeon , blinded to the administered anesthetic and the concentration of epinephrine , injected @:@,@ , @:@,@ , or @:@,@ ( @ , @ , or @ micrograms/ml ) epinephrine in saline of volumes sufficient for surgical need . the authors defined a positive response as three or more premature ventricular contractions ( pvcs ) in the @ min after starting the injection . no patient given either anesthetic developed any pvcs with epinephrine doses less than @ micrograms/kg . greater doses of epinephrine ( @-@ @ micrograms/kg ) produced positive responses at equal frequencies in the two anesthetic groups . the authors concluded that isoflurane and desflurane do not differ in their sensitization of human myocardium to the arrhythmogenic effects of exogenously administered epinephrine .
[ "inhaled anesthetics can alter the arrhythmogenicity of exogenously administered epinephrine .", "although swine anesthetized with desflurane or isoflurane do not differ in their arrhythmic response to exogenous epinephrine , the relative effect of epinephrine in the presence of these anesthetics in humans is untested .", "the authors compared the arrhythmogenicity of submucosally administered epinephrine in @ asa physical status @ and @ patients undergoing transsphenoidal resection of pituitary tumors who were randomly assigned to receive @-@ @ mac desflurane or isoflurane anesthesia .", "a surgeon , blinded to the administered anesthetic and the concentration of epinephrine , injected @:@,@ , @:@,@ , or @:@,@ ( @ , @ , or @ micrograms/ml ) epinephrine in saline of volumes sufficient for surgical need .", "the authors defined a positive response as three or more premature ventricular contractions ( pvcs ) in the @ min after starting the injection .", "no patient given either anesthetic developed any pvcs with epinephrine doses less than @ micrograms/kg .", "greater doses of epinephrine ( @-@ @ micrograms/kg ) produced positive responses at equal frequencies in the two anesthetic groups .", "the authors concluded that isoflurane and desflurane do not differ in their sensitization of human myocardium to the arrhythmogenic effects of exogenously administered epinephrine ." ]
[ "BACKGROUND", "BACKGROUND", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
15,769,772
black subjects with a family history of premature coronary heart disease ( chd ) have a marked excess risk , yet barriers prevent effective risk reduction . we tested a community-based multiple risk factor intervention ( community-based care [ cbc ] ) and compared it with `` enhanced '' primary care ( epc ) to reduce chd risk in high-risk black families . black @ - to @-year-old siblings of a proband with chd aged < @ years were randomized for care of bp > or = @/@ mm hg , ldl cholesterol > or = @ mmol/l , or current smoking to epc ( n = @ ) or cbc ( n = @ ) and monitored for @ year . epc and cbc were designed to eliminate barriers to care . the cbc group received care by a nurse practitioner and a community health worker in a community setting . the cbc group was @ times more likely to achieve goal levels of ldl cholesterol and blood pressure compared with the epc group ( @ % ci , @ to @ and @ to @ , respectively ) with adjustment for baseline levels of age , sex , education , and baseline use of medications . the cbc group demonstrated a significant reduction in global chd risk , whereas no reduction was seen in the epc group ( p < @ ) . eliminating known barriers may not be sufficient to reduce chd risk in primary care settings . an alternative community care model that addresses barriers may be a more effective way to ameliorate chd risk in high-risk black families .
[ "black subjects with a family history of premature coronary heart disease ( chd ) have a marked excess risk , yet barriers prevent effective risk reduction .", "we tested a community-based multiple risk factor intervention ( community-based care [ cbc ] ) and compared it with `` enhanced '' primary care ( epc ) to reduce chd risk in high-risk black families .", "black @ - to @-year-old siblings of a proband with chd aged < @ years were randomized for care of bp > or = @/@ mm hg , ldl cholesterol > or = @ mmol/l , or current smoking to epc ( n = @ ) or cbc ( n = @ ) and monitored for @ year .", "epc and cbc were designed to eliminate barriers to care .", "the cbc group received care by a nurse practitioner and a community health worker in a community setting .", "the cbc group was @ times more likely to achieve goal levels of ldl cholesterol and blood pressure compared with the epc group ( @ % ci , @ to @ and @ to @ , respectively ) with adjustment for baseline levels of age , sex , education , and baseline use of medications .", "the cbc group demonstrated a significant reduction in global chd risk , whereas no reduction was seen in the epc group ( p < @ ) .", "eliminating known barriers may not be sufficient to reduce chd risk in primary care settings .", "an alternative community care model that addresses barriers may be a more effective way to ameliorate chd risk in high-risk black families ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
22,793,957
this study was undertaken to compare the healing outcome of a short period ( @ weeks ) of intermaxillary fixation ( imf ) with conventional ( @-@ weeks ) imf in the management of fractures of the mandibular tooth-bearing area . this was a randomized controlled study conducted at the lagos university teaching hospital , lagos , nigeria , between november @ and january @ . subjects with minimally displaced mandibular fractures in the tooth-bearing area were randomly allocated into @ treatment groups : imf for @ weeks ( study group ) or imf for @ to @ weeks ( control group ) . for the purpose of study analysis , the primary predictor variable was the treatment ( imf for @ weeks vs imf for @-@ weeks ) . other predictor variables were the age and gender of subjects . the primary healing outcome was considered either satisfactory or unsatisfactory . the following outcome variables that described the healing process were also compared in the @ groups : healing time , postoperative infection , paresthesia , and maximal interincisal opening . loss of body weight and oral hygiene status at the end of treatment were compared in the @ groups . a value of p < @ was considered significant . satisfactory healing was observed in all cases in both groups . however , satisfactory healing was observed earlier ( @ @ weeks ) in the control group than in patients with the short imf period ( @ @ weeks ) ( p < @ ) . malocclusion that was amenable to selective grinding was the only complication seen in both groups ( n = @ in study group and n = @ in control group ) ( p = @ ) . subjects in the control group lost more weight after treatment than those in the study group ( p < @ ) . the recovery of interincisal mouth opening was also better in the study group than in the control group ( p < @ ) . the study group had better oral hygiene than the control group at the end of treatment . the healing outcome was comparable in both groups . however , the healing time was significantly longer in the group with the short imf period . the recovery of maximal mouth opening , oral hygiene status , and loss of weight body in the study group were significantly better than those in the control group . this study suggests that a short period ( @ weeks ) of imf in the management of minimally displaced mandibular fractures of the tooth-bearing area in young adults is a suitable alternative to the conventional method in terms of the healing outcome .
[ "this study was undertaken to compare the healing outcome of a short period ( @ weeks ) of intermaxillary fixation ( imf ) with conventional ( @-@ weeks ) imf in the management of fractures of the mandibular tooth-bearing area .", "this was a randomized controlled study conducted at the lagos university teaching hospital , lagos , nigeria , between november @ and january @ .", "subjects with minimally displaced mandibular fractures in the tooth-bearing area were randomly allocated into @ treatment groups : imf for @ weeks ( study group ) or imf for @ to @ weeks ( control group ) .", "for the purpose of study analysis , the primary predictor variable was the treatment ( imf for @ weeks vs imf for @-@ weeks ) .", "other predictor variables were the age and gender of subjects .", "the primary healing outcome was considered either satisfactory or unsatisfactory .", "the following outcome variables that described the healing process were also compared in the @ groups : healing time , postoperative infection , paresthesia , and maximal interincisal opening .", "loss of body weight and oral hygiene status at the end of treatment were compared in the @ groups .", "a value of p < @ was considered significant .", "satisfactory healing was observed in all cases in both groups .", "however , satisfactory healing was observed earlier ( @ @ weeks ) in the control group than in patients with the short imf period ( @ @ weeks ) ( p < @ ) .", "malocclusion that was amenable to selective grinding was the only complication seen in both groups ( n = @ in study group and n = @ in control group ) ( p = @ ) .", "subjects in the control group lost more weight after treatment than those in the study group ( p < @ ) .", "the recovery of interincisal mouth opening was also better in the study group than in the control group ( p < @ ) .", "the study group had better oral hygiene than the control group at the end of treatment .", "the healing outcome was comparable in both groups .", "however , the healing time was significantly longer in the group with the short imf period .", "the recovery of maximal mouth opening , oral hygiene status , and loss of weight body in the study group were significantly better than those in the control group .", "this study suggests that a short period ( @ weeks ) of imf in the management of minimally displaced mandibular fractures of the tooth-bearing area in young adults is a suitable alternative to the conventional method in terms of the healing outcome ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
21,294,416
to be a preliminary , prospective , randomized double blinded , placebo-controlled trial to evaluate the efficacy of morinda citrifolia linn or noni for the prevention of postoperative nausea and vomiting ( ponv ) in patients considered high risk for ponv after various types of surgery . the plant extract was prepared by boiling of dried noni fruit ( maturity stage @-@ ) then evaporated under standard procedure and processed into capsules . the doses were @ mg , @ mg and @ mg which are equivalent to @ , @ and @ g of dried noni fruit , respectively . one hundred patients of asa physical status i or ii , aged @-@ years , and considered at risk for ponv , were randomized to receive @ , @ , @ mg of noni extract or a placebo orally @ hours before surgery . standard general anesthetic technique and postoperative analgesia were employed . significantly fewer patients who had received the @ mg noni extract experienced nausea during the first @ hours compared to the placebo group ( @ % for the @ mg noni group and @ % for the placebo group , p-value = @ ) . the incidence of ponv in other time periods was not statistically different for all three noni doses compared to the placebo group . no side effects were reported in all groups . morinda citrifolia linn . has an antiemetic property and prophylactic noni extract at @ mg ( equivalent to @g of dried noni fruit or scopoletin @ microg ) effectively reduces the incidence of early postoperative nausea ( @-@ hours ) .
[ "to be a preliminary , prospective , randomized double blinded , placebo-controlled trial to evaluate the efficacy of morinda citrifolia linn or noni for the prevention of postoperative nausea and vomiting ( ponv ) in patients considered high risk for ponv after various types of surgery .", "the plant extract was prepared by boiling of dried noni fruit ( maturity stage @-@ ) then evaporated under standard procedure and processed into capsules .", "the doses were @ mg , @ mg and @ mg which are equivalent to @ , @ and @ g of dried noni fruit , respectively .", "one hundred patients of asa physical status i or ii , aged @-@ years , and considered at risk for ponv , were randomized to receive @ , @ , @ mg of noni extract or a placebo orally @ hours before surgery .", "standard general anesthetic technique and postoperative analgesia were employed .", "significantly fewer patients who had received the @ mg noni extract experienced nausea during the first @ hours compared to the placebo group ( @ % for the @ mg noni group and @ % for the placebo group , p-value = @ ) .", "the incidence of ponv in other time periods was not statistically different for all three noni doses compared to the placebo group .", "no side effects were reported in all groups .", "morinda citrifolia linn .", "has an antiemetic property and prophylactic noni extract at @ mg ( equivalent to @g of dried noni fruit or scopoletin @ microg ) effectively reduces the incidence of early postoperative nausea ( @-@ hours ) ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
19,262,561
to observe the efficacy and safety of rocaltrol ( calcitriol ) and/or caltrate d ( calicum carbonate plus vitamin d ) in elderly chinese women with osteopenia or osteoporosis . one hundred fifty chinese women aged over @ years with osteopenia or osteoporosis from three centers were randomly divided into two groups . seventy-six participants received caltrate d as one pill daily ; the other @ participants received @ mug caltrate d plus rocaltrol daily . the changes in bone mineral density ( bmd ) served as primary end-points . height changes , the presence of new vertebral fractures , muscle strength and balance were evaluated . the following are the mean percentage changes ( and sd ) in bmd over @ months : at l@-l@ , @ + / -@ in the caltrate d group and @ + / -@ in the rocaltrol + caltrate d group ( p = @ , by ancova ) ; at the femoral neck , @ + / -@ in the caltrate d group and @ + / -@ in the rocaltrol + caltrate d group ( p = @ , by ancova ) ; and in the trochanter , @ + / -@ in the caltrate d group and @ + / -@ in the rocaltrol + caltrate d group ( p = @ , by ancova ) . the stand and maximal forward reach test ( smfrt ) was significantly enhanced in both groups during the @ months of treatment , but no significant differences were found between these two groups . no severe adverse event related to these medications occurred throughout the study . treatment with rocaltrol plus caltrate d or caltrate d for @ months in elderly chinese postmenopausal women effectively increased bmd at the lumbar spine . rocaltrol plus caltrate d was more effective at the lumbar spine than caltrate d alone .
[ "to observe the efficacy and safety of rocaltrol ( calcitriol ) and/or caltrate d ( calicum carbonate plus vitamin d ) in elderly chinese women with osteopenia or osteoporosis .", "one hundred fifty chinese women aged over @ years with osteopenia or osteoporosis from three centers were randomly divided into two groups .", "seventy-six participants received caltrate d as one pill daily ; the other @ participants received @ mug caltrate d plus rocaltrol daily .", "the changes in bone mineral density ( bmd ) served as primary end-points .", "height changes , the presence of new vertebral fractures , muscle strength and balance were evaluated .", "the following are the mean percentage changes ( and sd ) in bmd over @ months : at l@-l@ , @ + / -@ in the caltrate d group and @ + / -@ in the rocaltrol + caltrate d group ( p = @ , by ancova ) ; at the femoral neck , @ + / -@ in the caltrate d group and @ + / -@ in the rocaltrol + caltrate d group ( p = @ , by ancova ) ; and in the trochanter , @ + / -@ in the caltrate d group and @ + / -@ in the rocaltrol + caltrate d group ( p = @ , by ancova ) .", "the stand and maximal forward reach test ( smfrt ) was significantly enhanced in both groups during the @ months of treatment , but no significant differences were found between these two groups .", "no severe adverse event related to these medications occurred throughout the study .", "treatment with rocaltrol plus caltrate d or caltrate d for @ months in elderly chinese postmenopausal women effectively increased bmd at the lumbar spine .", "rocaltrol plus caltrate d was more effective at the lumbar spine than caltrate d alone ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
10,401,802
to assess differences through grade @ in diet , physical activity , and related health indicators of students who participated in the child and adolescent trial for cardiovascular health ( catch ) school and family intervention from grades @ through @ . follow-up of the @-center , randomized , controlled field trial with @ intervention and @ control elementary schools . we studied @ ( @ % ) of the initial catch cohort of @ students from ethnically diverse backgrounds in california , louisiana , minnesota , and texas at grades @ , @ , and @ . self-reported daily energy intake from fat at baseline was virtually identical in the control ( @ % ) and intervention ( @ % ) groups . at grade @ , the intake for controls remained at @ % , while the intake for the intervention group declined to @ % ( p < @ ) . at grade @ , the between-group differential was maintained ( @ % vs @ % , p = @ ) . intervention students maintained significantly higher self-reported daily vigorous activity than control students ( p = @ ) , although the difference declined from @ minutes in grade @ to @ , @ , and @ minutes in grades @ , @ , and @ , respectively . significant differences in favor of the intervention students also persisted at grade @ for dietary knowledge and dietary intentions , but not for social support for physical activity . no impact on smoking behavior or stages of contemplating smoking was detected at grade @ . no significant differences were noted among physiologic indicators of body mass index , blood pressure , or serum lipid and cholesterol levels . the original catch results demonstrated that school-level interventions could modify school lunch and school physical education programs as well as influence student behaviors . this @-year follow-up without further intervention suggests that the behavioral changes initiated during the elementary school years persisted to early adolescence for self-reported dietary and physical activity behaviors .
[ "to assess differences through grade @ in diet , physical activity , and related health indicators of students who participated in the child and adolescent trial for cardiovascular health ( catch ) school and family intervention from grades @ through @ .", "follow-up of the @-center , randomized , controlled field trial with @ intervention and @ control elementary schools .", "we studied @ ( @ % ) of the initial catch cohort of @ students from ethnically diverse backgrounds in california , louisiana , minnesota , and texas at grades @ , @ , and @ .", "self-reported daily energy intake from fat at baseline was virtually identical in the control ( @ % ) and intervention ( @ % ) groups .", "at grade @ , the intake for controls remained at @ % , while the intake for the intervention group declined to @ % ( p < @ ) .", "at grade @ , the between-group differential was maintained ( @ % vs @ % , p = @ ) .", "intervention students maintained significantly higher self-reported daily vigorous activity than control students ( p = @ ) , although the difference declined from @ minutes in grade @ to @ , @ , and @ minutes in grades @ , @ , and @ , respectively .", "significant differences in favor of the intervention students also persisted at grade @ for dietary knowledge and dietary intentions , but not for social support for physical activity .", "no impact on smoking behavior or stages of contemplating smoking was detected at grade @ .", "no significant differences were noted among physiologic indicators of body mass index , blood pressure , or serum lipid and cholesterol levels .", "the original catch results demonstrated that school-level interventions could modify school lunch and school physical education programs as well as influence student behaviors .", "this @-year follow-up without further intervention suggests that the behavioral changes initiated during the elementary school years persisted to early adolescence for self-reported dietary and physical activity behaviors ." ]
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
8,381,146
intralesional vinblastine has been used to treat kaposi 's sarcoma associated with acquired immunodeficiency syndrome ( aids-ks ) . injections are painful and anticipated response rates are not well documented . eleven homosexual men were studied to evaluate the efficacy and pain associated with intralesional vinblastine with or without @ % bicarbonate buffered lidocaine ( bbl ) . six lesions on each patient were selected and treated with either vinblastine , vinblastine mixed with bbl , or vinblastine @ minutes after bbl injection . control lesions received bbl , saline , or no treatment . patients recorded injection pain on a visual analog scale . there was a complete or partial clinical response in @ % of vinblastine-treated lesions . pain scores for bbl , vinblastine , and the mixture of bbl and vinblastine were not statistically different . intralesional vinblastine is effective therapy for aids-ks . local anesthesia does not reduce efficacy of treatment , or reduce the pain experienced by the patient .
[ "intralesional vinblastine has been used to treat kaposi 's sarcoma associated with acquired immunodeficiency syndrome ( aids-ks ) .", "injections are painful and anticipated response rates are not well documented .", "eleven homosexual men were studied to evaluate the efficacy and pain associated with intralesional vinblastine with or without @ % bicarbonate buffered lidocaine ( bbl ) .", "six lesions on each patient were selected and treated with either vinblastine , vinblastine mixed with bbl , or vinblastine @ minutes after bbl injection .", "control lesions received bbl , saline , or no treatment .", "patients recorded injection pain on a visual analog scale .", "there was a complete or partial clinical response in @ % of vinblastine-treated lesions .", "pain scores for bbl , vinblastine , and the mixture of bbl and vinblastine were not statistically different .", "intralesional vinblastine is effective therapy for aids-ks .", "local anesthesia does not reduce efficacy of treatment , or reduce the pain experienced by the patient ." ]
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "CONCLUSIONS", "CONCLUSIONS" ]
21,863,462
although lumbar spinal fusion has been performed for more than @years , few studies have examined rehabilitation strategies for spinal fusion patients , and there is only sparse information about the patient 's activity level after surgery . the canadian occupational performance measure ( copm ) is a standardized semi-structured interview , developed to identify patients ' problems in relation to activities of daily living ( adl ) . the copm has neither been examined in a randomised clinical study nor employed in relation to lumbar spinal fusion patients . we aimed to examine whether or not the use of the semi-structured interview copm during in-hospital rehabilitation could : ( @ ) identify more adl-related problems of importance to the patients after discharge from the hospital , ( @ ) enhance the patients ' adl performance after discharge from hospital eighty-seven patients undergoing a lumbar spinal fusion caused by degenerative diseases were randomly assigned to either use of the copm or to standard treatment . use of the copm during hospitalization helped in identifying more adl problems encountered by patients during the first @months post-discharge period as copm served to identify more treatment goals and plans of action . use of the copm had no impact on the patients ' adl performance , and the difference is so small that copm may be of little clinical consequence .
[ "although lumbar spinal fusion has been performed for more than @years , few studies have examined rehabilitation strategies for spinal fusion patients , and there is only sparse information about the patient 's activity level after surgery .", "the canadian occupational performance measure ( copm ) is a standardized semi-structured interview , developed to identify patients ' problems in relation to activities of daily living ( adl ) .", "the copm has neither been examined in a randomised clinical study nor employed in relation to lumbar spinal fusion patients .", "we aimed to examine whether or not the use of the semi-structured interview copm during in-hospital rehabilitation could : ( @ ) identify more adl-related problems of importance to the patients after discharge from the hospital , ( @ ) enhance the patients ' adl performance after discharge from hospital", "eighty-seven patients undergoing a lumbar spinal fusion caused by degenerative diseases were randomly assigned to either use of the copm or to standard treatment .", "use of the copm during hospitalization helped in identifying more adl problems encountered by patients during the first @months post-discharge period as copm served to identify more treatment goals and plans of action .", "use of the copm had no impact on the patients ' adl performance , and the difference is so small that copm may be of little clinical consequence ." ]
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
17,626,912
several occupational exposures adversely affect lung function . this study reports the influence of continued occupational dust and fume exposures on the rate of decline of lung function in participants with early chronic obstructive pulmonary disease ( copd ) studied in a population-based study . subjects consisted of @,@ participants in the lung health study , a multicenter study of smoking cessation and anticholinergic bronchodilator administration in smokers with early copd ( @,@ men ; @,@ women ) . average post-bronchodilator fev@ at entry was @ % predicted for men and @ % predicted for women ; all participants had an fev@/fvc ratio less than @ . participants underwent a baseline evaluation and five annual follow-up assessments , including questionnaires and spirometry . the effect of ongoing dust or fume exposure on fev@ in each follow-up year was statistically evaluated with a mixed-effects regression model , which was adjusted for fev@ at entry , age , airway responsiveness to methacholine , baseline smoking intensity , and time-varying ( yearly ) smoking status during each follow-up year . in men with early copd , each year of continued fume exposure was associated with a @ % predicted reduction in post-bronchodilator fev@ % predicted . continued smoking and airway hyperresponsiveness were also associated with reduction in fev@ during each year of follow-up in both men and women . statistically significant effects of dust exposure on the rate of decline were not found , nor were effects of fume exposure noted in women . these results suggest a need for secondary prevention by controlling occupational fume exposures .
[ "several occupational exposures adversely affect lung function .", "this study reports the influence of continued occupational dust and fume exposures on the rate of decline of lung function in participants with early chronic obstructive pulmonary disease ( copd ) studied in a population-based study .", "subjects consisted of @,@ participants in the lung health study , a multicenter study of smoking cessation and anticholinergic bronchodilator administration in smokers with early copd ( @,@ men ; @,@ women ) .", "average post-bronchodilator fev@ at entry was @ % predicted for men and @ % predicted for women ; all participants had an fev@/fvc ratio less than @ .", "participants underwent a baseline evaluation and five annual follow-up assessments , including questionnaires and spirometry .", "the effect of ongoing dust or fume exposure on fev@ in each follow-up year was statistically evaluated with a mixed-effects regression model , which was adjusted for fev@ at entry , age , airway responsiveness to methacholine , baseline smoking intensity , and time-varying ( yearly ) smoking status during each follow-up year .", "in men with early copd , each year of continued fume exposure was associated with a @ % predicted reduction in post-bronchodilator fev@ % predicted .", "continued smoking and airway hyperresponsiveness were also associated with reduction in fev@ during each year of follow-up in both men and women .", "statistically significant effects of dust exposure on the rate of decline were not found , nor were effects of fume exposure noted in women .", "these results suggest a need for secondary prevention by controlling occupational fume exposures ." ]
[ "OBJECTIVE", "METHODS", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
15,182,981
to identify differences in lower extremity kinematic movement patterns between genders during walking through the application of an expected perturbation . randomized limb kinematics were compared between healthy active males and females . lower extremity kinematics during jump landing and cutting have been implicated as a potential source of the discrepancy in anterior cruciate ligament injury rates between genders . kinematic differences between genders have been identified during tasks that are not provocative of anterior cruciate ligament injury but do result in increased ligament strain . repetition of movement patterns that increase anterior cruciate ligament strain may increase the likelihood they will be reproduced during athletic tasks that produce force loads that exceed anterior cruciate ligament tensile strength . twenty subjects ( @ women , @ men ) classified as a level i or ii athlete underwent motion analyses while performing self-paced walking trials . five trials were undisturbed , and five each with a platform translating either laterally or anteriorly at heel contact . sagittal , frontal , and transverse hip angles as well as sagittal and frontal knee angles were collected during stance . excursions in the frontal and transverse planes were greater at the hip and knee for females compared to males in each walking condition . the rate of these excursions also occurred more rapidly for females than males . there was no difference for joint angles at initial contact between genders , and there was no difference in the amount of sagittal plane excursion for the hip and knee when comparing genders . females demonstrate characteristics during both normal and perturbed gait that may potentially contribute to increased anterior cruciate ligament strain . repetition of these potentially harmful movement patterns during provocative athletic maneuvers may lead to anterior cruciate ligament injury . females exhibit lower extremity kinematic patterns that differ from males . female kinematic patterns may contribute to an increased risk for anterior cruciate ligament injury .
[ "to identify differences in lower extremity kinematic movement patterns between genders during walking through the application of an expected perturbation .", "randomized limb kinematics were compared between healthy active males and females .", "lower extremity kinematics during jump landing and cutting have been implicated as a potential source of the discrepancy in anterior cruciate ligament injury rates between genders .", "kinematic differences between genders have been identified during tasks that are not provocative of anterior cruciate ligament injury but do result in increased ligament strain .", "repetition of movement patterns that increase anterior cruciate ligament strain may increase the likelihood they will be reproduced during athletic tasks that produce force loads that exceed anterior cruciate ligament tensile strength .", "twenty subjects ( @ women , @ men ) classified as a level i or ii athlete underwent motion analyses while performing self-paced walking trials .", "five trials were undisturbed , and five each with a platform translating either laterally or anteriorly at heel contact .", "sagittal , frontal , and transverse hip angles as well as sagittal and frontal knee angles were collected during stance .", "excursions in the frontal and transverse planes were greater at the hip and knee for females compared to males in each walking condition .", "the rate of these excursions also occurred more rapidly for females than males .", "there was no difference for joint angles at initial contact between genders , and there was no difference in the amount of sagittal plane excursion for the hip and knee when comparing genders .", "females demonstrate characteristics during both normal and perturbed gait that may potentially contribute to increased anterior cruciate ligament strain .", "repetition of these potentially harmful movement patterns during provocative athletic maneuvers may lead to anterior cruciate ligament injury .", "females exhibit lower extremity kinematic patterns that differ from males .", "female kinematic patterns may contribute to an increased risk for anterior cruciate ligament injury ." ]
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
9,871,425
oxycodone is metabolized in the liver by means of o-demethylation to form oxymorphone in a reaction catalyzed by the enzyme cytochrome p@ @d@ ( cyp@d@ ) . this enzyme is expressed as @ phenotypes ( extensive and poor metabolizers ) . several drugs are metabolized by cyp@d@ , and clinically relevant drug interactions may occur . the aim of this study was to evaluate the role of oxymorphone in mediating the opioid effects of oxycodone by means of blocking cyp@d@ with quinidine . ten healthy extensive metabolizers were administered @ mg controlled-release oxycodone after premedication with placebo or @ mg quinidine in this randomized , double-blind crossover study . a dose of @ mg quinidine was administered @ hours later . plasma opioid concentrations , subjective pharmacodynamic ratings , and psychomotor function were assessed for @ hours after drug administration . no oxymorphone was detected at any time after quinidine premedication in @ of @ subjects . plasma oxycodone ( difference not significant ) and noroxycodone ( p < @ ) concentrations were greater after quinidine pretreatment . prevention of the production of oxymorphone by quinidine did not affect the psychomotor or subjective drug effects of oxycodone . no difference in number of adverse effects was observed after the @ pretreatments . a significant reduction in plasma oxymorphone levels did not substantially alter the pharmacodynamic effects of oxycodone . analgesia was not evaluated because pain was not present .
[ "oxycodone is metabolized in the liver by means of o-demethylation to form oxymorphone in a reaction catalyzed by the enzyme cytochrome p@ @d@ ( cyp@d@ ) .", "this enzyme is expressed as @ phenotypes ( extensive and poor metabolizers ) .", "several drugs are metabolized by cyp@d@ , and clinically relevant drug interactions may occur .", "the aim of this study was to evaluate the role of oxymorphone in mediating the opioid effects of oxycodone by means of blocking cyp@d@ with quinidine .", "ten healthy extensive metabolizers were administered @ mg controlled-release oxycodone after premedication with placebo or @ mg quinidine in this randomized , double-blind crossover study .", "a dose of @ mg quinidine was administered @ hours later .", "plasma opioid concentrations , subjective pharmacodynamic ratings , and psychomotor function were assessed for @ hours after drug administration .", "no oxymorphone was detected at any time after quinidine premedication in @ of @ subjects .", "plasma oxycodone ( difference not significant ) and noroxycodone ( p < @ ) concentrations were greater after quinidine pretreatment .", "prevention of the production of oxymorphone by quinidine did not affect the psychomotor or subjective drug effects of oxycodone .", "no difference in number of adverse effects was observed after the @ pretreatments .", "a significant reduction in plasma oxymorphone levels did not substantially alter the pharmacodynamic effects of oxycodone .", "analgesia was not evaluated because pain was not present ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
17,716,936
safety and reactogenicity of a new heptavalent dtpw-hbv/hib-menac ( diphtheria , tetanus , whole cell pertussis-hepatitis b virus/haemophilus influenzae type b-neisseria meningitidis serogroups a and c ) vaccine was compared with a widely used pentavalent dtpw-hbv/hib vaccine . three phase iii randomized studies comparable in design and methodology , in which healthy infants received dtpw-hbv/hib-menac ( n = @ ) or dtpw-hbv/hib ( n = @ ) at @ , @ , and @ months , were pooled for analysis . solicited symptoms were recorded for @ days , and unsolicited adverse events for @ days after each dose . serious adverse events ( saes ) were recorded throughout the studies . there were no significant differences between the two groups in the proportion of subjects with fever > @ degrees c or > @ degrees c ( p < @ ) . compared to group dtpw-hbv/hib , a significantly higher percentage of subjects in group dtpw-hbv/hib-menac reported fever > @ degrees c ( @ % vs. @ % , p = @ ) . fever subsided quickly , did not lead to differences in attendance to medical services and did not increase from dose to dose . sixty-seven saes were reported , @/@ ( @ % ) in group dtpw-hbv/hib-menac and @/@ ( @ % ) in the dtpw-hbv/hib group . overall , the heptavalent and pentavalent vaccines had similar safety profiles . the difference observed in percentage of subjects with fever > @ degrees c did not lead to differences in medically attended visits for fever .
[ "safety and reactogenicity of a new heptavalent dtpw-hbv/hib-menac ( diphtheria , tetanus , whole cell pertussis-hepatitis b virus/haemophilus influenzae type b-neisseria meningitidis serogroups a and c ) vaccine was compared with a widely used pentavalent dtpw-hbv/hib vaccine .", "three phase iii randomized studies comparable in design and methodology , in which healthy infants received dtpw-hbv/hib-menac ( n = @ ) or dtpw-hbv/hib ( n = @ ) at @ , @ , and @ months , were pooled for analysis .", "solicited symptoms were recorded for @ days , and unsolicited adverse events for @ days after each dose .", "serious adverse events ( saes ) were recorded throughout the studies .", "there were no significant differences between the two groups in the proportion of subjects with fever > @ degrees c or > @ degrees c ( p < @ ) .", "compared to group dtpw-hbv/hib , a significantly higher percentage of subjects in group dtpw-hbv/hib-menac reported fever > @ degrees c ( @ % vs. @ % , p = @ ) .", "fever subsided quickly , did not lead to differences in attendance to medical services and did not increase from dose to dose .", "sixty-seven saes were reported , @/@ ( @ % ) in group dtpw-hbv/hib-menac and @/@ ( @ % ) in the dtpw-hbv/hib group .", "overall , the heptavalent and pentavalent vaccines had similar safety profiles .", "the difference observed in percentage of subjects with fever > @ degrees c did not lead to differences in medically attended visits for fever ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
21,692,844
to describe satisfaction with continuous glucose monitoring in type @ diabetes ; to correlate continuous glucose monitoring satisfaction scores with usage ; and to identify common themes in perceived benefits and barriers of monitoring reported by adults , youths and the parents of youths in the juvenile diabetes research foundation continuous glucose monitoring trials . the continuous glucose monitoring satisfaction scale questionnaire was completed after @ months of monitoring . participants also answered open-ended queries of positive and negative attributes of continuous glucose monitoring . more frequent monitoring was associated with higher satisfaction for adults ( n = @ ) , youths ( n = @ ) and parents of youths ( n = @ ) ( all p < @ ) in both the ` benefits ' and ` hassles ' sub-scales of the continuous glucose monitoring satisfaction scale , but the greatest differences between the two groups involved scores on hassle items . common barriers to monitoring use included insertion pain , system alarms and body issues ; while common benefits included glucose trend data , opportunities to self-correct out-of-range glucose levels and to detect hypoglycaemia . as frequent use of continuous glucose monitoring is associated with improved glycaemic control without increased hypoglycaemia it is important to overcome barriers , reinforce benefits and set realistic expectations for this technology in order to promote its more consistent and frequent use in individuals with type @ diabetes .
[ "to describe satisfaction with continuous glucose monitoring in type @ diabetes ; to correlate continuous glucose monitoring satisfaction scores with usage ; and to identify common themes in perceived benefits and barriers of monitoring reported by adults , youths and the parents of youths in the juvenile diabetes research foundation continuous glucose monitoring trials .", "the continuous glucose monitoring satisfaction scale questionnaire was completed after @ months of monitoring .", "participants also answered open-ended queries of positive and negative attributes of continuous glucose monitoring .", "more frequent monitoring was associated with higher satisfaction for adults ( n = @ ) , youths ( n = @ ) and parents of youths ( n = @ ) ( all p < @ ) in both the ` benefits ' and ` hassles ' sub-scales of the continuous glucose monitoring satisfaction scale , but the greatest differences between the two groups involved scores on hassle items .", "common barriers to monitoring use included insertion pain , system alarms and body issues ; while common benefits included glucose trend data , opportunities to self-correct out-of-range glucose levels and to detect hypoglycaemia .", "as frequent use of continuous glucose monitoring is associated with improved glycaemic control without increased hypoglycaemia it is important to overcome barriers , reinforce benefits and set realistic expectations for this technology in order to promote its more consistent and frequent use in individuals with type @ diabetes ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
11,783,329
to observe the clinical effect of xinyikang oral liquid ( xyk ) in treating viral myocarditis patients of qi-yin deficiency and evil-toxin encroaching heart type . randomized controlled method was adopted , the @ cases in the xyk group received xyk and @ cases in the control group received qidong yixin oral liquid treatment for @ weeks as a therapeutic course . their symptoms , signs , white blood cell count ( wbc ) , erythrocyte sedimentation rate ( esr ) , lactate , aspartate aminotransferase ( ast ) dehydrogenase ( ldh ) , creatine phosphokinase ( cpk ) , creatine phosphokinase isoenzyme ( cpk-mb ) , electrocardiogram ( ecg ) and dynamic ecg changes before and after treatment were observed . the improvement on chest stuffiness , short breath , fatigue and spontaneous perspiration in the treatment group was better than those in the control group ( p < @ ) and xyk showed obvious improving effect on esr , ast , ldh , cpk and cpk-mb ( p < @ or @ ) . there was no adverse reaction or side-toxic effects revealed in using xyk . xyk has significant therapeutic effect in treating viral myocarditis .
[ "to observe the clinical effect of xinyikang oral liquid ( xyk ) in treating viral myocarditis patients of qi-yin deficiency and evil-toxin encroaching heart type .", "randomized controlled method was adopted , the @ cases in the xyk group received xyk and @ cases in the control group received qidong yixin oral liquid treatment for @ weeks as a therapeutic course .", "their symptoms , signs , white blood cell count ( wbc ) , erythrocyte sedimentation rate ( esr ) , lactate , aspartate aminotransferase ( ast ) dehydrogenase ( ldh ) , creatine phosphokinase ( cpk ) , creatine phosphokinase isoenzyme ( cpk-mb ) , electrocardiogram ( ecg ) and dynamic ecg changes before and after treatment were observed .", "the improvement on chest stuffiness , short breath , fatigue and spontaneous perspiration in the treatment group was better than those in the control group ( p < @ ) and xyk showed obvious improving effect on esr , ast , ldh , cpk and cpk-mb ( p < @ or @ ) .", "there was no adverse reaction or side-toxic effects revealed in using xyk .", "xyk has significant therapeutic effect in treating viral myocarditis ." ]
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
24,462,735
little is known about the benefit of antiviral therapy for hepatitis b e antigen ( hbeag ) - positive patients with high viral load and normal levels of alanine aminotransferase . we evaluated the effects of single and combination therapies in immune-tolerant patients with chronic hepatitis b. in a double-blind study , nucleos ( t ) ide-nave patients with high levels of hepatitis b virus ( hbv ) dna who were positive for hbeag and had normal levels of alanine aminotransferase were randomly assigned to groups given either oral tenofovir disoproxil fumarate ( tdf , @ mg ) and placebo ( n = @ ) or a combination of tdf ( @ mg ) and emtricitabine ( @ mg , n = @ ) for @ weeks . the primary end point was proportion of patients with serum levels of hbv dna < @ iu/ml at week @ . the study population ( mean age was @ years ; @ % were asian ) was predominantly infected with hbv genotypes b and c ( @ % ) , @ % were hbeag positive with a mean baseline level of hbv dna of @ log@ iu/ml . at week @ , @ % of patients ( @ of @ ) in the tdf + placebo group and @ % of patients ( @ of @ ) in the tdf + emtricitabine group had levels of hbv dna < @ iu/ml ( p = @ ) . no patients were found to have viral resistance to therapy . hbeag seroconversion occurred in @ patients ( @ % ) , all in the tdf + placebo group ; no patient had loss of hepatitis b surface antigen . in multivariate analysis , female sex ( odds ratio = @ ; p = @ ) and tdf + emtricitabine treatment ( odds ratio = @ ; p = @ ) were associated with a favorable response . both regimens were well tolerated . in hbeag-positive patients with chronic hbv infection , high viral loads , normal levels of alanine aminotransferase , and therapy with the combination of tdf and emtricitabine provided better viral suppression than tdf alone , although rates of hbeag seroconversion and hepatitis b surface antigen loss were low .
[ "little is known about the benefit of antiviral therapy for hepatitis b e antigen ( hbeag ) - positive patients with high viral load and normal levels of alanine aminotransferase .", "we evaluated the effects of single and combination therapies in immune-tolerant patients with chronic hepatitis b.", "in a double-blind study , nucleos ( t ) ide-nave patients with high levels of hepatitis b virus ( hbv ) dna who were positive for hbeag and had normal levels of alanine aminotransferase were randomly assigned to groups given either oral tenofovir disoproxil fumarate ( tdf , @ mg ) and placebo ( n = @ ) or a combination of tdf ( @ mg ) and emtricitabine ( @ mg , n = @ ) for @ weeks .", "the primary end point was proportion of patients with serum levels of hbv dna < @ iu/ml at week @ .", "the study population ( mean age was @ years ; @ % were asian ) was predominantly infected with hbv genotypes b and c ( @ % ) , @ % were hbeag positive with a mean baseline level of hbv dna of @ log@ iu/ml .", "at week @ , @ % of patients ( @ of @ ) in the tdf + placebo group and @ % of patients ( @ of @ ) in the tdf + emtricitabine group had levels of hbv dna < @ iu/ml ( p = @ ) .", "no patients were found to have viral resistance to therapy .", "hbeag seroconversion occurred in @ patients ( @ % ) , all in the tdf + placebo group ; no patient had loss of hepatitis b surface antigen .", "in multivariate analysis , female sex ( odds ratio = @ ; p = @ ) and tdf + emtricitabine treatment ( odds ratio = @ ; p = @ ) were associated with a favorable response .", "both regimens were well tolerated .", "in hbeag-positive patients with chronic hbv infection , high viral loads , normal levels of alanine aminotransferase , and therapy with the combination of tdf and emtricitabine provided better viral suppression than tdf alone , although rates of hbeag seroconversion and hepatitis b surface antigen loss were low ." ]
[ "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
17,577,218
this randomized , noncomparative , multicenter , clinical trial evaluated ixabepilone or mitoxantrone/prednisone ( mp ) as second-line chemotherapy for taxane-refractory , hormone-refractory , prostate cancer ( hrpc ) . patients with hrpc that progressed during or within @ days of cessation of taxane chemotherapy were randomly selected with equal probability to ixabepilone @ mg/m ( @ ) intravenously every @ weeks , or mitoxantrone @ mg/m ( @ ) intravenously every @ weeks and prednisone @ mg orally twice daily . treatment continued until progression or toxicity ; crossover was allowed . forty-one patients were accrued to each arm of the study . the median number of cycles administered for each arm was @ . median survival from protocol entry was @ months with ixabepilone and @ months with mp . prostate-specific antigen ( psa ) declines of > or = @ % were observed in @ % of ixabepilone ( @ % ci , @-@ ) and @ % of second-line mp patients ( @ % ci , @-@ ) . partial responses were observed in @ of @ ixabepilone and in @ of @ mp patients with evaluable measurable disease . median duration of second-line ixabepilone and mp treatment was @ months and @ months , respectively . for third-line crossover treatment , psa declines of > or = @ % were observed in @ of @ ixabepilone-treated and @ of @ mp-treated patients . prior taxane response was associated with an increased likelihood of second-line ixabepilone or mp response . low baseline lactate dehydrogenase and absence of visceral metastases independently predicted improved survival . the most common grade @/@ toxicity associated with second-line treatment was neutropenia ( @ % of ixabepilone patients and @ % of mp patients ) . ixabepilone and mp had modest activity as second-line chemotherapy for docetaxel-refractory hrpc . the median survival for the entire cohort treated in this study was @ months .
[ "this randomized , noncomparative , multicenter , clinical trial evaluated ixabepilone or mitoxantrone/prednisone ( mp ) as second-line chemotherapy for taxane-refractory , hormone-refractory , prostate cancer ( hrpc ) .", "patients with hrpc that progressed during or within @ days of cessation of taxane chemotherapy were randomly selected with equal probability to ixabepilone @ mg/m ( @ ) intravenously every @ weeks , or mitoxantrone @ mg/m ( @ ) intravenously every @ weeks and prednisone @ mg orally twice daily .", "treatment continued until progression or toxicity ; crossover was allowed .", "forty-one patients were accrued to each arm of the study .", "the median number of cycles administered for each arm was @ .", "median survival from protocol entry was @ months with ixabepilone and @ months with mp .", "prostate-specific antigen ( psa ) declines of > or = @ % were observed in @ % of ixabepilone ( @ % ci , @-@ ) and @ % of second-line mp patients ( @ % ci , @-@ ) .", "partial responses were observed in @ of @ ixabepilone and in @ of @ mp patients with evaluable measurable disease .", "median duration of second-line ixabepilone and mp treatment was @ months and @ months , respectively .", "for third-line crossover treatment , psa declines of > or = @ % were observed in @ of @ ixabepilone-treated and @ of @ mp-treated patients .", "prior taxane response was associated with an increased likelihood of second-line ixabepilone or mp response .", "low baseline lactate dehydrogenase and absence of visceral metastases independently predicted improved survival .", "the most common grade @/@ toxicity associated with second-line treatment was neutropenia ( @ % of ixabepilone patients and @ % of mp patients ) .", "ixabepilone and mp had modest activity as second-line chemotherapy for docetaxel-refractory hrpc .", "the median survival for the entire cohort treated in this study was @ months ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
14,985,796
the purpose of this clinical trial was to compare the clinical performance of a new composite resin using two different kind of light curing systems , one conventional and one turbo boosted in a split-mouth design , by using both systems for direct bonding of orthodontic stainless steel brackets in every patient . fifty patients , @ females and @ males , of which @ were adults ( > @ years of age ) with fixed appliances were followed for a mean period of @ months ( range @-@ months ) . the performance of @ steel brackets was evaluated : @ were bonded with a conventional light curing ( kulzer light curing machine ) , curing every bracket for @ seconds using quick cure composite resin ( reliance orthodontics ) , @ were bonded with a new curing light machine ( reliance ortho @ curing light with power slot ) , curing every bracket for @ seconds . brackets were bonded both on permanent and on deciduous teeth , since many of these patients were growing patients . the conventional light curing recorded an overall failure rate ( @ brackets - @,@ % ) significantly higher ( p < @ ) than power slot light curing ( @ brackets -@,@ % ) . there were no statistically significant differences ( p > @ ) between the failure rates in the upper and lower arches with either light curing systems and also in between anterior and posterior areas . a significant difference was evident , however , among the failure rate of upper total and lower total ( p < @ ) brackets bonded with both systems and was more evident in upper arches bonded with conventional curing system ( p < @ ) . it was evident also a higher failure rate in the upper arch compared to the lower arch bonded with conventional light ( p < @ ) . the power slot light curing was more effective . but both bonding systems failed mainly at the enamel-adhesive interface , without causing damage to the enamel .
[ "the purpose of this clinical trial was to compare the clinical performance of a new composite resin using two different kind of light curing systems , one conventional and one turbo boosted in a split-mouth design , by using both systems for direct bonding of orthodontic stainless steel brackets in every patient .", "fifty patients , @ females and @ males , of which @ were adults ( > @ years of age ) with fixed appliances were followed for a mean period of @ months ( range @-@ months ) .", "the performance of @ steel brackets was evaluated : @ were bonded with a conventional light curing ( kulzer light curing machine ) , curing every bracket for @ seconds using quick cure composite resin ( reliance orthodontics ) , @ were bonded with a new curing light machine ( reliance ortho @ curing light with power slot ) , curing every bracket for @ seconds .", "brackets were bonded both on permanent and on deciduous teeth , since many of these patients were growing patients .", "the conventional light curing recorded an overall failure rate ( @ brackets - @,@ % ) significantly higher ( p < @ ) than power slot light curing ( @ brackets -@,@ % ) .", "there were no statistically significant differences ( p > @ ) between the failure rates in the upper and lower arches with either light curing systems and also in between anterior and posterior areas .", "a significant difference was evident , however , among the failure rate of upper total and lower total ( p < @ ) brackets bonded with both systems and was more evident in upper arches bonded with conventional curing system ( p < @ ) .", "it was evident also a higher failure rate in the upper arch compared to the lower arch bonded with conventional light ( p < @ ) .", "the power slot light curing was more effective .", "but both bonding systems failed mainly at the enamel-adhesive interface , without causing damage to the enamel ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
22,173,608
to investigate the effect of treatment of multiple myeloma ( mm ) - associated spinal fracture with percutaneous vertebroplasty ( pvp ) and chemotherapy . patients with mm-associated spinal fracture were randomly divided into combined ( pvp and chemotherapy ) treatment group ( n = @ ) and single chemotherapy group ( n = @ ) . for the combined treatment group , bone cement was injected into vertebral body via dsa guided-percutaneous puncture . m@ scheme was used for both groups . and a @-year follow-up was conducted for the study . at the @-year follow-up visits , pvp combined with chemotherapy achieved complete remission ( cr ) in six patients ( @ % ) ; near complete remission ( ncr ) in ten patients ( @ % ) ; partial remission ( pr ) in nine patients ( @ % ) ; minimal response ( mr ) in three patients ( @ % ) ; no change ( nc ) in four patients ( @ % ) , and disease progression ( dp ) in five patients ( @ % ) . only chemotherapy alone resulted in @ cr ( @ % ) ; @ ncr ( @ % ) ; @ pr ( @ % ) ; @ mr ( @ % ) ; @ nc ( @ % ) , and @ dp ( @ % ) . while the overall response rate ( orr ) in the combined treatment group ( @ % ) and the single chemotherapy group ( @ % ) were significantly different , their visual analog pain scales ( @ @ and @ @ , respectively ) and karnofsky performance scores ( @ @ and @ @ , respectively ) were significantly improved after treatment ( p = @ and p = @ , respectively ) . and the orr between the two groups were significantly different ( p = @ ) . percutaneous vertebroplasty is a minimally invasive surgery for mm-associated pathologic fracture . pvp had the characteristics of minimal trauma , easy operation and less complication . pvp can achieve long-term analgesic effect , and enhance the spinal stability .
[ "to investigate the effect of treatment of multiple myeloma ( mm ) - associated spinal fracture with percutaneous vertebroplasty ( pvp ) and chemotherapy .", "patients with mm-associated spinal fracture were randomly divided into combined ( pvp and chemotherapy ) treatment group ( n = @ ) and single chemotherapy group ( n = @ ) .", "for the combined treatment group , bone cement was injected into vertebral body via dsa guided-percutaneous puncture .", "m@ scheme was used for both groups .", "and a @-year follow-up was conducted for the study .", "at the @-year follow-up visits , pvp combined with chemotherapy achieved complete remission ( cr ) in six patients ( @ % ) ; near complete remission ( ncr ) in ten patients ( @ % ) ; partial remission ( pr ) in nine patients ( @ % ) ; minimal response ( mr ) in three patients ( @ % ) ; no change ( nc ) in four patients ( @ % ) , and disease progression ( dp ) in five patients ( @ % ) .", "only chemotherapy alone resulted in @ cr ( @ % ) ; @ ncr ( @ % ) ; @ pr ( @ % ) ; @ mr ( @ % ) ; @ nc ( @ % ) , and @ dp ( @ % ) .", "while the overall response rate ( orr ) in the combined treatment group ( @ % ) and the single chemotherapy group ( @ % ) were significantly different , their visual analog pain scales ( @ @ and @ @ , respectively ) and karnofsky performance scores ( @ @ and @ @ , respectively ) were significantly improved after treatment ( p = @ and p = @ , respectively ) .", "and the orr between the two groups were significantly different ( p = @ ) .", "percutaneous vertebroplasty is a minimally invasive surgery for mm-associated pathologic fracture .", "pvp had the characteristics of minimal trauma , easy operation and less complication .", "pvp can achieve long-term analgesic effect , and enhance the spinal stability ." ]
[ "OBJECTIVE", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
23,993,469
to compare the efficacy and safety of acarbose plus metformin fixed-dose combination ( fdc ) versus acarbose monotherapy for type @ diabetes ( t@d ) . eligible t@d patients undergoing treatment with diet control only or oral antidiabetic medications were run-in on acarbose @mg thrice-daily for @ weeks , then randomised either to continue this monotherapy , or to acarbose @mg plus metformin hydrochloride @mg fdc ( acarbose/metformin fdc ) , each thrice-daily for @ weeks . acarbose/metformin fdc therapy significantly reduced hba@c , fasting plasma glucose ( fpg ) , and postprandial plasma glucose ( ppg ) from baseline ( all p < @ ) with superior efficacy compared with acarbose monotherapy ( between-group differences ; hba@c -@ % ; fpg -@ mg/dl ; ppg -@ mg/dl ; all p < @ ) . proportionally more patients treated with acarbose/metformin fdc achieved hba@c < @ % ( @ % vs. @ % , p < @ ) . both treatments reduced bodyweight ( p < @ ) , with a significant between-group difference ( -@ kg , p < @ ) favouring acarbose/metformin fdc . hypoglycaemia was not reported with either treatment , and the incidence of other adverse events did not differ significantly between the groups . compared with acarbose monotherapy , acarbose/metformin fdc has superior antihyperglycaemic efficacy , brings proportionally more t@d patients to hba@c goal , and further reduces bodyweight . acarbose/metformin fdc is well-tolerated without significant risk of hypoglycaemia and is a potentially advantageous therapy for t@d .
[ "to compare the efficacy and safety of acarbose plus metformin fixed-dose combination ( fdc ) versus acarbose monotherapy for type @ diabetes ( t@d ) .", "eligible t@d patients undergoing treatment with diet control only or oral antidiabetic medications were run-in on acarbose @mg thrice-daily for @ weeks , then randomised either to continue this monotherapy , or to acarbose @mg plus metformin hydrochloride @mg fdc ( acarbose/metformin fdc ) , each thrice-daily for @ weeks .", "acarbose/metformin fdc therapy significantly reduced hba@c , fasting plasma glucose ( fpg ) , and postprandial plasma glucose ( ppg ) from baseline ( all p < @ ) with superior efficacy compared with acarbose monotherapy ( between-group differences ; hba@c -@ % ; fpg -@ mg/dl ; ppg -@ mg/dl ; all p < @ ) .", "proportionally more patients treated with acarbose/metformin fdc achieved hba@c < @ % ( @ % vs. @ % , p < @ ) .", "both treatments reduced bodyweight ( p < @ ) , with a significant between-group difference ( -@ kg , p < @ ) favouring acarbose/metformin fdc .", "hypoglycaemia was not reported with either treatment , and the incidence of other adverse events did not differ significantly between the groups .", "compared with acarbose monotherapy , acarbose/metformin fdc has superior antihyperglycaemic efficacy , brings proportionally more t@d patients to hba@c goal , and further reduces bodyweight .", "acarbose/metformin fdc is well-tolerated without significant risk of hypoglycaemia and is a potentially advantageous therapy for t@d ." ]
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
15,280,678
screening of donor-specific antibodies or alloantibodies after kidney transplantation has not been performed routinely . the aim of this study was to evaluate the humoral antidonor and alloresponse of immunologically low-risk recipients of cadaveric renal allografts during the first posttransplant year . alloresponse against the donor was analyzed by means of t-cell immunoglobulin ( ig ) g and igm and b cell igg flow cytometric crossmatch ( fcxm ) tests with sera from days @ , @ , @ , and @ posttransplant . in addition , panel reactive anti-human leukocyte antigen ( hla ) class i and class ii antibodies ( pra i and pra ii ) were analyzed using flow cytometric methods . the recipients were treated either with a low initial cyclosporine regimen with single-bolus antithymocyte globulin ( atg ) or basiliximab induction or conventional cyclosporine triple therapy . no significant posttransplant anti-hla class i or class ii sensitization was found in the recipients as a whole . recipients receiving a single-bolus atg showed significantly higher proportion of pra i positivity in the day @ sample compared with the other groups . flow cytometric donor-specific t - and b-cell igg alloresponses remained low , but the proportion of t-cell igm crossmatch-positive recipients increased during the study . positive t-cell igm fcxm was found to be associated with acute rejection episodes and cytomegalovirus ( cmv ) infections . in immunologically low-risk kidney-graft recipients , positive t-cell igm fcxm at transplantation was found to be a risk factor for rejection episodes . conversion of t-cell igm fcxm to positive was found to be associated with cmv infections .
[ "screening of donor-specific antibodies or alloantibodies after kidney transplantation has not been performed routinely .", "the aim of this study was to evaluate the humoral antidonor and alloresponse of immunologically low-risk recipients of cadaveric renal allografts during the first posttransplant year .", "alloresponse against the donor was analyzed by means of t-cell immunoglobulin ( ig ) g and igm and b cell igg flow cytometric crossmatch ( fcxm ) tests with sera from days @ , @ , @ , and @ posttransplant .", "in addition , panel reactive anti-human leukocyte antigen ( hla ) class i and class ii antibodies ( pra i and pra ii ) were analyzed using flow cytometric methods .", "the recipients were treated either with a low initial cyclosporine regimen with single-bolus antithymocyte globulin ( atg ) or basiliximab induction or conventional cyclosporine triple therapy .", "no significant posttransplant anti-hla class i or class ii sensitization was found in the recipients as a whole .", "recipients receiving a single-bolus atg showed significantly higher proportion of pra i positivity in the day @ sample compared with the other groups .", "flow cytometric donor-specific t - and b-cell igg alloresponses remained low , but the proportion of t-cell igm crossmatch-positive recipients increased during the study .", "positive t-cell igm fcxm was found to be associated with acute rejection episodes and cytomegalovirus ( cmv ) infections .", "in immunologically low-risk kidney-graft recipients , positive t-cell igm fcxm at transplantation was found to be a risk factor for rejection episodes .", "conversion of t-cell igm fcxm to positive was found to be associated with cmv infections ." ]
[ "BACKGROUND", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
11,547,294
although low-dose aprotinin administered after cardiopulmonary bypass has been reported to reduce mediastinal blood loss and blood product requirements in patients not taking aspirin , it is unknown whether low-dose postoperative aprotinin has any beneficial effects in patients undergoing coronary artery bypass operations who are at high risk of excessive postoperative bleeding and increased transfusion requirements because of aspirin use until just before the operation . fifty-five patients undergoing primary coronary artery operations with cardiopulmonary bypass who continued taking aspirin ( @ mg/d ) until the day before the operation were enrolled in a prospective , randomized , double-blind trial to receive a single dose of either placebo ( n = @ ) or @ x @ ( @ ) kallikrein inhibiting units of aprotinin ( n = @ ) at the time of sternal skin closure . patients in the aprotinin group had a lower rate ( @ + / - @ vs @ + / - @ ml/h [ mean + / - standard deviation ] , p < @ ) and total volume of mediastinal drainage ( @ + / - @ vs @ + / - @ ml , p < @ ) , as well as a shorter duration of mediastinal drain tube insertion ( @ + / - @ vs @ + / - @ hours , p < @ ) . in addition , a smaller proportion of patients receiving aprotinin required a blood product ( @ % vs @ % , p = @ ) , resulting in a reduction in the use of packed cells by @ % ( p = @ ) , platelets by @ % ( p = @ ) , fresh frozen plasma by @ % ( p = @ ) , and total blood products by @ % ( p = @ ) in this group . these results suggest that postoperative administration of low-dose aprotinin in patients taking aspirin until just before primary coronary artery operations with cardiopulmonary bypass not only reduces the rate and total amount of postoperative mediastinal blood loss but also lowers postoperative blood product use .
[ "although low-dose aprotinin administered after cardiopulmonary bypass has been reported to reduce mediastinal blood loss and blood product requirements in patients not taking aspirin , it is unknown whether low-dose postoperative aprotinin has any beneficial effects in patients undergoing coronary artery bypass operations who are at high risk of excessive postoperative bleeding and increased transfusion requirements because of aspirin use until just before the operation .", "fifty-five patients undergoing primary coronary artery operations with cardiopulmonary bypass who continued taking aspirin ( @ mg/d ) until the day before the operation were enrolled in a prospective , randomized , double-blind trial to receive a single dose of either placebo ( n = @ ) or @ x @ ( @ ) kallikrein inhibiting units of aprotinin ( n = @ ) at the time of sternal skin closure .", "patients in the aprotinin group had a lower rate ( @ + / - @ vs @ + / - @ ml/h [ mean + / - standard deviation ] , p < @ ) and total volume of mediastinal drainage ( @ + / - @ vs @ + / - @ ml , p < @ ) , as well as a shorter duration of mediastinal drain tube insertion ( @ + / - @ vs @ + / - @ hours , p < @ ) .", "in addition , a smaller proportion of patients receiving aprotinin required a blood product ( @ % vs @ % , p = @ ) , resulting in a reduction in the use of packed cells by @ % ( p = @ ) , platelets by @ % ( p = @ ) , fresh frozen plasma by @ % ( p = @ ) , and total blood products by @ % ( p = @ ) in this group .", "these results suggest that postoperative administration of low-dose aprotinin in patients taking aspirin until just before primary coronary artery operations with cardiopulmonary bypass not only reduces the rate and total amount of postoperative mediastinal blood loss but also lowers postoperative blood product use ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
19,065,889
to explore the intestinal mucosal barrier protective effect of herbal medicine compound tongfu granule ( ctg ) in patients with liver cirrhosis of decompensation stage . fifty patients enrolled were randomly assigned to the control group ( @ cases ) and the ctg group ( @ cases ) , and @ healthy adults were set up as normal control . after @-week treatment , the intestinal permeability ( ip , represented by urinary lactulose/mannitol excretion rate ) , plasma endotoxin ( edt ) level , and change of enteric bacteria ( eb ) in patients were observed before and after treatment , and compared with those in the normal control . before treatment , cirrhotic patients showed significantly higher levels of ip , edt , and intestinal bacilli , but a lower amount of enteric bifidobacteria as compared with those the normal control . after @-week treatment , levels of edt and urinary excretion rate of lactulose in the ctg group were lowered more significantly than those in the control group ( p < @ ) , while the amount of bifidobacteria in the ctg group increased accompanied with intestinal bacilli significantly lowered to near the levels in the normal control ( p < @ , p < @ ) . ctg can improve the intestinal barrier function , correct the intestinal bacteria disturbance , and significantly reduce the entero-derived endotoxemia in cirrhotic patients of decompensation stage .
[ "to explore the intestinal mucosal barrier protective effect of herbal medicine compound tongfu granule ( ctg ) in patients with liver cirrhosis of decompensation stage .", "fifty patients enrolled were randomly assigned to the control group ( @ cases ) and the ctg group ( @ cases ) , and @ healthy adults were set up as normal control .", "after @-week treatment , the intestinal permeability ( ip , represented by urinary lactulose/mannitol excretion rate ) , plasma endotoxin ( edt ) level , and change of enteric bacteria ( eb ) in patients were observed before and after treatment , and compared with those in the normal control .", "before treatment , cirrhotic patients showed significantly higher levels of ip , edt , and intestinal bacilli , but a lower amount of enteric bifidobacteria as compared with those the normal control .", "after @-week treatment , levels of edt and urinary excretion rate of lactulose in the ctg group were lowered more significantly than those in the control group ( p < @ ) , while the amount of bifidobacteria in the ctg group increased accompanied with intestinal bacilli significantly lowered to near the levels in the normal control ( p < @ , p < @ ) .", "ctg can improve the intestinal barrier function , correct the intestinal bacteria disturbance , and significantly reduce the entero-derived endotoxemia in cirrhotic patients of decompensation stage ." ]
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
24,372,521
traditional chinese acupuncture ( tca ) is an effective alternative treatment in migraine headache . the aim of this study was to compare the therapeutic effect of yamamoto new scalp acupuncture ( ynsa ) , a recently developed microcupuncture system , with tca for the prophylaxis and treatment of migraine headache . in a randomized clinical trial , @ patients with migraine headache were assigned to receive ynsa or tca . a pain visual analogue scale ( vas ) and migraine therapy assessment questionnaire ( mtaq ) were completed before treatment , after @ and @ sections of treatment , and @ month after completion of therapy . all the recruited patients completed the study . baseline characteristics were similar between the two groups . frequency and severity of migraine attacks , nausea , the need for rescue treatment , and work absence rate decreased similarly in both groups . recovery from headache and ability to continue daily activities @ hours after medical treatment showed similar improvement in both groups ( p > @ ) . classic acupuncture and ynsa are similarly effective in the prophylaxis and treatment of migraine headache and may be considered as alternatives to pharmacotherapy .
[ "traditional chinese acupuncture ( tca ) is an effective alternative treatment in migraine headache .", "the aim of this study was to compare the therapeutic effect of yamamoto new scalp acupuncture ( ynsa ) , a recently developed microcupuncture system , with tca for the prophylaxis and treatment of migraine headache .", "in a randomized clinical trial , @ patients with migraine headache were assigned to receive ynsa or tca .", "a pain visual analogue scale ( vas ) and migraine therapy assessment questionnaire ( mtaq ) were completed before treatment , after @ and @ sections of treatment , and @ month after completion of therapy .", "all the recruited patients completed the study .", "baseline characteristics were similar between the two groups .", "frequency and severity of migraine attacks , nausea , the need for rescue treatment , and work absence rate decreased similarly in both groups .", "recovery from headache and ability to continue daily activities @ hours after medical treatment showed similar improvement in both groups ( p > @ ) .", "classic acupuncture and ynsa are similarly effective in the prophylaxis and treatment of migraine headache and may be considered as alternatives to pharmacotherapy ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
23,307,206
to determine the clinical sensitivity , specificity , negative predictive value , and positive predictive value of a rapid point-of-care diagnostic test to detect elevated matrix metalloproteinase @ levels ( inflammadry ) . in a prospective , sequential , masked , multicenter clinical trial , inflammadry was performed on @ patients : @ patients with clinical signs and symptoms of dysfunctional tear syndrome ( dry eyes ) and @ healthy individuals serving as controls . participants were assessed as healthy controls or for a clinical diagnosis of dry eye using the ocular surface disease index , schirmer tear test , tear breakup time , and keratoconjunctival staining . the sensitivity and specificity of inflammadry were compared with clinical assessment . inflammadry showed sensitivity of @ % ( in @ of @ patients ) , specificity of @ % ( @ of @ ) , negative predictive value of @ % ( @ of @ ) , and positive predictive value of @ % ( @ of @ ) . compared with clinical assessment , inflammadry is sensitive and specific in diagnosing dry eye . dry eye is often underdiagnosed resulting from poor communication between the clinical assessment of dry eye severity between clinicians and patients . this often leads to a lack of effective treatment . matrix metalloproteinase @ is an inflammatory biomarker that has been shown to be elevated in the tears of patients with dry eyes . the ability to accurately detect elevated matrix metalloproteinase @ levels may lead to earlier diagnosis , more appropriate treatment , and better management of ocular surface disease . preoperative and perioperative management of inflammation related to dry eyes may reduce dry eyes that develop after laser in situ keratomileusis , improve wound healing , and reduce flap complications . recognition of inflammation may allow for targeted perioperative therapeutic management of care for patients who undergo cataract and refractive surgery and improve outcomes . clinicaltrials.gov identifier : nct@ .
[ "to determine the clinical sensitivity , specificity , negative predictive value , and positive predictive value of a rapid point-of-care diagnostic test to detect elevated matrix metalloproteinase @ levels ( inflammadry ) .", "in a prospective , sequential , masked , multicenter clinical trial , inflammadry was performed on @ patients : @ patients with clinical signs and symptoms of dysfunctional tear syndrome ( dry eyes ) and @ healthy individuals serving as controls .", "participants were assessed as healthy controls or for a clinical diagnosis of dry eye using the ocular surface disease index , schirmer tear test , tear breakup time , and keratoconjunctival staining .", "the sensitivity and specificity of inflammadry were compared with clinical assessment .", "inflammadry showed sensitivity of @ % ( in @ of @ patients ) , specificity of @ % ( @ of @ ) , negative predictive value of @ % ( @ of @ ) , and positive predictive value of @ % ( @ of @ ) .", "compared with clinical assessment , inflammadry is sensitive and specific in diagnosing dry eye .", "dry eye is often underdiagnosed resulting from poor communication between the clinical assessment of dry eye severity between clinicians and patients .", "this often leads to a lack of effective treatment .", "matrix metalloproteinase @ is an inflammatory biomarker that has been shown to be elevated in the tears of patients with dry eyes .", "the ability to accurately detect elevated matrix metalloproteinase @ levels may lead to earlier diagnosis , more appropriate treatment , and better management of ocular surface disease .", "preoperative and perioperative management of inflammation related to dry eyes may reduce dry eyes that develop after laser in situ keratomileusis , improve wound healing , and reduce flap complications .", "recognition of inflammation may allow for targeted perioperative therapeutic management of care for patients who undergo cataract and refractive surgery and improve outcomes .", "clinicaltrials.gov identifier : nct@ ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
20,692,774
to assess the effects of ambulation during the first stage of labor on the duration of labor and other maternal and infant outcomes . a prospective randomized trial conducted from @stnovember@ to @stmarch@ at the department of obstetrics and gynecology , chu farhat hached , sousse , tunisia . two hundred mothers with uncomplicated term pregnancies were randomly assigned to one of two groups : first group ( @ parturients ) authorized to ambulate until @cm of cervical dilation and a second group ( @ parturients ) confined to bed in dorsal or lateral recumbence . upright position reduces significantly ( for about @ % ) the duration of the first stage of labor ( p < @ ) , the pain intensity , the oxytocin consumption ( p = @ ) , the rate of delivery by cesarean section and of instrumental deliveries . upright position leads also to a net improvement of the maternal outcome ( @ % side effects versus @ % ) and the fetal outcome ( net improvement of the apgar 's score at first and fifth minute , and reduction of a factor@ of the rate of transfer to the neonatology clinical care unit . our study allowed to confirm the benefits of ambulation on labor progress as well as on the maternal comfort and the maternofetal outcome .
[ "to assess the effects of ambulation during the first stage of labor on the duration of labor and other maternal and infant outcomes .", "a prospective randomized trial conducted from @stnovember@ to @stmarch@ at the department of obstetrics and gynecology , chu farhat hached , sousse , tunisia .", "two hundred mothers with uncomplicated term pregnancies were randomly assigned to one of two groups : first group ( @ parturients ) authorized to ambulate until @cm of cervical dilation and a second group ( @ parturients ) confined to bed in dorsal or lateral recumbence .", "upright position reduces significantly ( for about @ % ) the duration of the first stage of labor ( p < @ ) , the pain intensity , the oxytocin consumption ( p = @ ) , the rate of delivery by cesarean section and of instrumental deliveries .", "upright position leads also to a net improvement of the maternal outcome ( @ % side effects versus @ % ) and the fetal outcome ( net improvement of the apgar 's score at first and fifth minute , and reduction of a factor@ of the rate of transfer to the neonatology clinical care unit .", "our study allowed to confirm the benefits of ambulation on labor progress as well as on the maternal comfort and the maternofetal outcome ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
24,051,968
the aim of this trial is to evaluate the role lactobacillus paracasei in bell 's stage @ in order to prevent the clinical progression to stage @ . a prospective study was approved and started in december @ . patients were infants with birth weight @ to @ g. one group received probiotic supplementation ( l. paracasei susp.paracasei f-@ ) and the control group received only standard medical treatment . the primary outcome was the progression to stage @ as defined by bell 's modified criteria . inclusion and exclusion criteria were created and discussed with parents before treatment . thirty-two patients ( stage @ nec ) were considered eligible for the study . group a : @ patients and group b : @ patients . three patients in group a and six patients in group b had a clinical history of bell 's stage @ nec ( p < @ ) ; oral supplementation of l. paracasei reduced the clinical progression of nec . it was considered that an improvement in intestinal motility might have contributed to this result . the use of lactobacillus paracasei subsp . paracasei f-@ is safe ; the low progression rate to stage @ nec suggests that the use of this probiotic in stage @ nec could be a valuable therapeutic option .
[ "the aim of this trial is to evaluate the role lactobacillus paracasei in bell 's stage @ in order to prevent the clinical progression to stage @ .", "a prospective study was approved and started in december @ .", "patients were infants with birth weight @ to @ g.", "one group received probiotic supplementation ( l. paracasei susp.paracasei f-@ ) and the control group received only standard medical treatment .", "the primary outcome was the progression to stage @ as defined by bell 's modified criteria .", "inclusion and exclusion criteria were created and discussed with parents before treatment .", "thirty-two patients ( stage @ nec ) were considered eligible for the study .", "group a : @ patients and group b : @ patients .", "three patients in group a and six patients in group b had a clinical history of bell 's stage @ nec ( p < @ ) ; oral supplementation of l. paracasei reduced the clinical progression of nec .", "it was considered that an improvement in intestinal motility might have contributed to this result .", "the use of lactobacillus paracasei subsp .", "paracasei f-@ is safe ; the low progression rate to stage @ nec suggests that the use of this probiotic in stage @ nec could be a valuable therapeutic option ." ]
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
15,243,303
type ii diabetes is often associated with high blood pressure , elevated sympathetic activity , and high plasma insulin levels . hypoglycemic agents may negatively interfere with blood pressure control , sympathetic activity , and plasma insulin level ; therefore the choice of treatment in type ii diabetes may be crucial . we aimed to compare the effects of two hypoglycemic drugs on blood glucose , blood pressure , sympathetic activity , and insulin levels in type ii diabetic and hypertensive patients . forty-eight ( @m , @f ) type ii diabetic , hypertensive , and hyperlipidemic subjects were enrolled and treated for @ weeks with an ace inhibitor ( cilazapril ) and a statin ( simvastatin ) . they were then randomized into two groups to receive a thiazolidinedione ( rosiglitazone ; ros ) or a sulfonylurea ( glibenclamide ; glb ) for @ weeks . blood biochemistry , blood pressure , plasma insulin , endothelial function , and sympathetic skin activity were measured before and after treatment . a significant drop in systolic and diastolic blood pressure by @ + / - @ mm hg and @ + / - @ mm hg respectively ; a reduction in plasma insulin concentration by @ + / - @ mu/l and a decline in skin sympathetic activity were observed in the group receiving ros . the glb group showed an increase in systolic blood pressure by @ + / - @ mm hg , no change in diastolic blood pressure , significant elevation in plasma insulin concentration by @ + / - @ mu/l , and augmentation of sympathetic activity . no significant changes in endothelial function were observed in either group . rosiglitazone improved both plasma glucose and blood pressure levels , probably by attenuation of hyperinsulinemia and sympathetic activity , while glibenclamide worsened blood pressure control possibly by elevation of insulin levels and activation of the sympathetic system .
[ "type ii diabetes is often associated with high blood pressure , elevated sympathetic activity , and high plasma insulin levels .", "hypoglycemic agents may negatively interfere with blood pressure control , sympathetic activity , and plasma insulin level ; therefore the choice of treatment in type ii diabetes may be crucial .", "we aimed to compare the effects of two hypoglycemic drugs on blood glucose , blood pressure , sympathetic activity , and insulin levels in type ii diabetic and hypertensive patients .", "forty-eight ( @m , @f ) type ii diabetic , hypertensive , and hyperlipidemic subjects were enrolled and treated for @ weeks with an ace inhibitor ( cilazapril ) and a statin ( simvastatin ) .", "they were then randomized into two groups to receive a thiazolidinedione ( rosiglitazone ; ros ) or a sulfonylurea ( glibenclamide ; glb ) for @ weeks .", "blood biochemistry , blood pressure , plasma insulin , endothelial function , and sympathetic skin activity were measured before and after treatment .", "a significant drop in systolic and diastolic blood pressure by @ + / - @ mm hg and @ + / - @ mm hg respectively ; a reduction in plasma insulin concentration by @ + / - @ mu/l and a decline in skin sympathetic activity were observed in the group receiving ros .", "the glb group showed an increase in systolic blood pressure by @ + / - @ mm hg , no change in diastolic blood pressure , significant elevation in plasma insulin concentration by @ + / - @ mu/l , and augmentation of sympathetic activity .", "no significant changes in endothelial function were observed in either group .", "rosiglitazone improved both plasma glucose and blood pressure levels , probably by attenuation of hyperinsulinemia and sympathetic activity , while glibenclamide worsened blood pressure control possibly by elevation of insulin levels and activation of the sympathetic system ." ]
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
12,492,743
we have previously reported , in an uncontrolled trial , an improvement in fatigue scores in patients with primary biliary cirrhosis given oral antioxidant supplementation . we now present data from a controlled trial . sixty-one patients with primary biliary cirrhosis-associated fatigue were randomized into a double-blind , placebo-controlled , cross-over trial . participants received @ weeks each of placebo and antioxidant supplementation ( vitamins a , c and e , selenium , methionine and ubiquinone ) in random order , separated by a @-week washout period . the primary trial outcome ( fatigue ) was assessed using the fisk scale . other symptoms of primary biliary cirrhosis were measured using likert and visual analogue scales . forty-four patients completed both arms of the trial . no significant changes in fatigue were recorded in the active phase of treatment ( median improvement in fisk score , @ ; p = @ ) . small improvements in fisk scores were recorded during placebo therapy ( median improvement , @ ; p = @ ) . neither medication was associated with improvement in any other symptoms related to primary biliary cirrhosis . adverse effects were more common during active therapy and were mild and self-limiting . one patient died from unrelated causes during active treatment . although oral antioxidant supplementation appears to be safe , we could not find any evidence for a beneficial effect on fatigue or other liver-related symptoms .
[ "we have previously reported , in an uncontrolled trial , an improvement in fatigue scores in patients with primary biliary cirrhosis given oral antioxidant supplementation .", "we now present data from a controlled trial .", "sixty-one patients with primary biliary cirrhosis-associated fatigue were randomized into a double-blind , placebo-controlled , cross-over trial .", "participants received @ weeks each of placebo and antioxidant supplementation ( vitamins a , c and e , selenium , methionine and ubiquinone ) in random order , separated by a @-week washout period .", "the primary trial outcome ( fatigue ) was assessed using the fisk scale .", "other symptoms of primary biliary cirrhosis were measured using likert and visual analogue scales .", "forty-four patients completed both arms of the trial .", "no significant changes in fatigue were recorded in the active phase of treatment ( median improvement in fisk score , @ ; p = @ ) .", "small improvements in fisk scores were recorded during placebo therapy ( median improvement , @ ; p = @ ) .", "neither medication was associated with improvement in any other symptoms related to primary biliary cirrhosis .", "adverse effects were more common during active therapy and were mild and self-limiting .", "one patient died from unrelated causes during active treatment .", "although oral antioxidant supplementation appears to be safe , we could not find any evidence for a beneficial effect on fatigue or other liver-related symptoms ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
1,986,895
to compare a simplified method of measuring extravascular lung water ( evlw ) using only a single indicator ( evlw-si ) with the standard double indicator dilution technique ( evlw-di ) . direct comparison of evlw-si with evlw-di in @ critically ill patients . a general medical icu in a university-affiliated hospital . nine men and nine women , ages @ to @ yr . six patients were in shock ( four from septic shock ) , and @ were in respiratory failure . evlw-di and cardiac output were measured in triplicate during injection of cold indocyanine green dye . cardiac output was calculated both from pulmonary artery ( copa ) and femoral artery ( cofem-di ) thermal dilution signals . evlw-si and cofem-si were also measured during three additional injections of cold saline using only thermal signals from the pulmonary and femoral arteries . order of measurements was random . evlw-si was measured in ten patients while blood was withdrawn through the femoral catheter and in ten patients without blood drawn through the femoral catheter . a total of @ comparisons were made . although the overall correlations were good ( r@ = @ ) , evlw-si systematically overestimated evlw-di ( p less than @ ) . this difference was greater when evlw-si was measured without blood withdrawal through the femoral catheter . in this subgroup , mean values for evlw by the two methods were within @ % of one another in only two of ten patients , in contrast to the results in six of eight patients in which blood was withdrawn through the catheter . cofem-si and cofem-di also overestimated copa . theoretically , neither injection of green dye nor blood withdrawal should be necessary during measurements of evlw-si , making it a simpler technique for bedside use than evlw-di . however , significant discrepancies exist between the two techniques . some of this difference is apparently due to technical factors related to catheter design . in any case , we can not recommend use of the single indicator dilution technique at present to estimate evlw .
[ "to compare a simplified method of measuring extravascular lung water ( evlw ) using only a single indicator ( evlw-si ) with the standard double indicator dilution technique ( evlw-di ) .", "direct comparison of evlw-si with evlw-di in @ critically ill patients .", "a general medical icu in a university-affiliated hospital .", "nine men and nine women , ages @ to @ yr .", "six patients were in shock ( four from septic shock ) , and @ were in respiratory failure .", "evlw-di and cardiac output were measured in triplicate during injection of cold indocyanine green dye .", "cardiac output was calculated both from pulmonary artery ( copa ) and femoral artery ( cofem-di ) thermal dilution signals .", "evlw-si and cofem-si were also measured during three additional injections of cold saline using only thermal signals from the pulmonary and femoral arteries .", "order of measurements was random .", "evlw-si was measured in ten patients while blood was withdrawn through the femoral catheter and in ten patients without blood drawn through the femoral catheter .", "a total of @ comparisons were made .", "although the overall correlations were good ( r@ = @ ) , evlw-si systematically overestimated evlw-di ( p less than @ ) .", "this difference was greater when evlw-si was measured without blood withdrawal through the femoral catheter .", "in this subgroup , mean values for evlw by the two methods were within @ % of one another in only two of ten patients , in contrast to the results in six of eight patients in which blood was withdrawn through the catheter .", "cofem-si and cofem-di also overestimated copa .", "theoretically , neither injection of green dye nor blood withdrawal should be necessary during measurements of evlw-si , making it a simpler technique for bedside use than evlw-di .", "however , significant discrepancies exist between the two techniques .", "some of this difference is apparently due to technical factors related to catheter design .", "in any case , we can not recommend use of the single indicator dilution technique at present to estimate evlw ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
14,650,366
the dose-effect relationship of nifuratel ( cas @-@-@ ) + nystatin ( cas @-@-@ , cas @-@-@ ) ( macmiror complex ) in topical treatment of vulvo-vaginitis was studied . sixty patients with trichomoniasis and/or candidiasis were randomized to : @ ) nifuratel @ mg/nystatin @ iu , @ ) nifuratel @ mg/nystatin @ iu , @ ) nifuratel @ mg/nystatin @ iu . undistinguishable ovules were intravaginally applied qd for @ days . the dose-effect relationship was assessed by ancova . after @ days the microbiological cure rate occurred in @ % of patients in the least dose , in @ % in the middle dose and in @ % in the highest dose group ( p = @ ) . after @ days of treatment , the microbiological cure rate increased to @ % , @ % , and @ % , respectively ( p = @ ) . clinical signs and symptoms gradually disappeared in a dose - and time-dependent manner . no relapse has been observed after @ day-follow up on @ patients . the results confirmed a linear relationship between nifuratel + nystatin dose and effect . the least effective dose was nifuratel @ mg + nystatin @,@ iu once daily for @ days and the best dose in terms of risk/benefit ratio was nifuratel @ mg + nystatin @,@ iu once daily for @ days .
[ "the dose-effect relationship of nifuratel ( cas @-@-@ ) + nystatin ( cas @-@-@ , cas @-@-@ ) ( macmiror complex ) in topical treatment of vulvo-vaginitis was studied .", "sixty patients with trichomoniasis and/or candidiasis were randomized to : @ ) nifuratel @ mg/nystatin @ iu , @ ) nifuratel @ mg/nystatin @ iu , @ ) nifuratel @ mg/nystatin @ iu .", "undistinguishable ovules were intravaginally applied qd for @ days .", "the dose-effect relationship was assessed by ancova .", "after @ days the microbiological cure rate occurred in @ % of patients in the least dose , in @ % in the middle dose and in @ % in the highest dose group ( p = @ ) .", "after @ days of treatment , the microbiological cure rate increased to @ % , @ % , and @ % , respectively ( p = @ ) .", "clinical signs and symptoms gradually disappeared in a dose - and time-dependent manner .", "no relapse has been observed after @ day-follow up on @ patients .", "the results confirmed a linear relationship between nifuratel + nystatin dose and effect .", "the least effective dose was nifuratel @ mg + nystatin @,@ iu once daily for @ days and the best dose in terms of risk/benefit ratio was nifuratel @ mg + nystatin @,@ iu once daily for @ days ." ]
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
22,717,961
surgical site infection ( ssi ) is the third most frequent nosocomial infection , and accounts for @-@ % of all infections . while the treatment of ssi can be very costly , previous results indicated that triclosan may reduce ssi rate . therefore , we carried out a prospective randomised trial to further evaluate the effect of triclosan after elective colorectal surgery . seven surgical units in hungary were involved in a prospective , randomised , multicentric clinical trial to compare triclosan coated ( pds plus ) and uncoated ( pds ii ) sutures for abdominal wall closure in elective colorectal surgery . pre - and perioperative variables were recorded in an online database . the primary aims of the study were to determine the incidence of ssi and the pathogens associated with it , as well as evaluation of additional cost of treatment . @ patients were randomised . ssi occurred in @ cases ( @ % ) , of those @ ( @ % ) from the triclosan group ( n = @ ) and @ ( @ % ) from the uncoated group ( n = @ , p = @ ) . in @ ( @ % ) cases late appearance of ssi was detected , of those @ patients with triclosan coated suture ( @ % ) and @ patients with uncoated suture ( @ % , p = @ ) . there was no difference between the type of incisions or elective colon and rectal resections in terms of incidence of ssi . beneficial effect of triclosan against gram positive bacteria could not be confirmed in our study due to the relatively low number of patients with ssi . furthermore , triclosan did not influence the incidence of ssi due to gram negative bacteria . ssi rate decreased by @ % compared to our previous study , however , it was regardless of the use of coated or uncoated pds loop . finally , operative factors were more important than patient 's risk factors in terms of incidence of ssi . in case ssi developed , delayed discharge from hospital as well as special wound care significantly increased overall cost of treatment .
[ "surgical site infection ( ssi ) is the third most frequent nosocomial infection , and accounts for @-@ % of all infections .", "while the treatment of ssi can be very costly , previous results indicated that triclosan may reduce ssi rate .", "therefore , we carried out a prospective randomised trial to further evaluate the effect of triclosan after elective colorectal surgery .", "seven surgical units in hungary were involved in a prospective , randomised , multicentric clinical trial to compare triclosan coated ( pds plus ) and uncoated ( pds ii ) sutures for abdominal wall closure in elective colorectal surgery .", "pre - and perioperative variables were recorded in an online database .", "the primary aims of the study were to determine the incidence of ssi and the pathogens associated with it , as well as evaluation of additional cost of treatment .", "@ patients were randomised .", "ssi occurred in @ cases ( @ % ) , of those @ ( @ % ) from the triclosan group ( n = @ ) and @ ( @ % ) from the uncoated group ( n = @ , p = @ ) .", "in @ ( @ % ) cases late appearance of ssi was detected , of those @ patients with triclosan coated suture ( @ % ) and @ patients with uncoated suture ( @ % , p = @ ) .", "there was no difference between the type of incisions or elective colon and rectal resections in terms of incidence of ssi .", "beneficial effect of triclosan against gram positive bacteria could not be confirmed in our study due to the relatively low number of patients with ssi .", "furthermore , triclosan did not influence the incidence of ssi due to gram negative bacteria .", "ssi rate decreased by @ % compared to our previous study , however , it was regardless of the use of coated or uncoated pds loop .", "finally , operative factors were more important than patient 's risk factors in terms of incidence of ssi .", "in case ssi developed , delayed discharge from hospital as well as special wound care significantly increased overall cost of treatment ." ]
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS" ]
24,108,521
this article provides new data on a controversial issue , the influence of doses on the diffusion characteristics of @ botulinum toxins type a. objective to assess the fields of effect of abobotulinumtoxina and onabotulinumtoxina at the same labeled unit dose ( @:@ u ) comparing sweat gland and muscle activity . a prospective , single-center , randomized , double-blind study was conducted at the brazilian center for studies in dermatology in porto alegre , brazil . the participants included @ women . each patient received @ u of abobotulinumtoxina on one side of the forehead and @ u of onabotulinumtoxina on the other side . horizontal and vertical diameter and area of the fields of anhidrotic effect , the amplitude of evoked compound muscle action potentials , and the @-point validated wrinkle severity scale were assessed at @ days . the horizontal and vertical diameters of the fields of effect and the areas were significantly larger for onabotulinumtoxina than those obtained for abobotulinumtoxina . there were no significant differences between the products in the wrinkle severity scale scores and evoked compound muscle action potentials . onabotulinumtoxina had significantly more diffusion than abobotulinumtoxina when isovolumetric injections of the same labeled unit dose of the products were injected . conclusions and relevance although many studies state that diffusion is product dependent and abobotulinumtoxina diffuses more than onabotulinumtoxina , findings from the present study confirm that diffusion is dose dependent and the more potent dose tested diffuses more . trial registration clinicaltrials.gov identifier : nct@ .
[ "this article provides new data on a controversial issue , the influence of doses on the diffusion characteristics of @ botulinum toxins type a. objective to assess the fields of effect of abobotulinumtoxina and onabotulinumtoxina at the same labeled unit dose ( @:@ u ) comparing sweat gland and muscle activity .", "a prospective , single-center , randomized , double-blind study was conducted at the brazilian center for studies in dermatology in porto alegre , brazil .", "the participants included @ women .", "each patient received @ u of abobotulinumtoxina on one side of the forehead and @ u of onabotulinumtoxina on the other side .", "horizontal and vertical diameter and area of the fields of anhidrotic effect , the amplitude of evoked compound muscle action potentials , and the @-point validated wrinkle severity scale were assessed at @ days .", "the horizontal and vertical diameters of the fields of effect and the areas were significantly larger for onabotulinumtoxina than those obtained for abobotulinumtoxina .", "there were no significant differences between the products in the wrinkle severity scale scores and evoked compound muscle action potentials .", "onabotulinumtoxina had significantly more diffusion than abobotulinumtoxina when isovolumetric injections of the same labeled unit dose of the products were injected .", "conclusions and relevance although many studies state that diffusion is product dependent and abobotulinumtoxina diffuses more than onabotulinumtoxina , findings from the present study confirm that diffusion is dose dependent and the more potent dose tested diffuses more .", "trial registration clinicaltrials.gov identifier : nct@ ." ]